Clinical Research Directory

Steady Together Fall Prevention Program in the Home

The purpose of the research study is to assess the efficacy of the occupational therapy Steady Together Fall Prevention Program in the Home for persons with Parkinson's Disease (PwP) who are members of InMotion. InMotion is a community wellness center that offers a variety of programs for PwP. The goal of the program is to prolong safe and independent living of PwP within their homes through fall prevention. Objectives are: 1) to identify areas in the home that are barriers to safe and accessible functioning for PwP with a focus on fall prevention; 2) To recommend assistive equipment, performance strategies, and home modifications as well as helpful resources to enhance safety and accessibility within the home. 3) to improve accessibility of the home; 4) to improve the PwP's safety confidence within their home. Research questions are: 1. Do participants have improved safety confidence in their homes as relates to falls after completing the program 2. Is home more accessible after completing program 3. What areas of the home pose the most fall risk among this population 4. What types of modifications and assistive devices help to reduce falls among this population 5. Does the program help to reduce falls among this population Participants will complete an initial intake form (30 minutes); they will participate in a 2 hour home assessment performed by occupational therapists using the Home for Life Design (HfLD platform in which they will be asked to identify areas of their home they have fall safety concerns; they will rate the safety of these spaces; they will demonstrate activities of daily living done in spaces and the occupational therapist will rate accessibility of these spaces; they will participate in a 30 minute meeting with the occupational therapist to review report with recommendations and resources and develop an agreed upon action plan; they will implement action plan; they will participate in a one hour reassessment; participate in a follow up 30 minute phone interview one year later. Total time commitment is 4 hours.

Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are: 1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty? 2. Are the effects maintained after the treatment ends? 3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works. Participants will: 1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision 2. Visit the clinic at specific time points for movement assessments 3. Complete online questionnaires about symptoms and quality of life

Adapting rHIRE and Sleep Monitoring in Parkinson's Disease

Exercise is a primary intervention for symptom management in Parkinson's Disease (PD). However, challenges related to transportation, mobility, and socioeconomic factors often hinder consistent participation in exercise programs. To promote increased access and participation, remote exercise programs offer a promising solution. The investigators previously showed that laboratory-based, high-intensity resistance exercise improves sleep efficiency in individuals with PD in a randomized, controlled, clinical trial. The investigators aim to adapt this protocol for remote delivery and to evaluate the usability of a remote sleep-monitoring device in people with Parkinson's Disease (PwP). Guided by the IDEAS framework for digital health intervention design, the investigators will modify the exercise protocol to ensure safety, accessibility, and fidelity in a home setting. Specific aims include: (1) assessing the adaptability of the HIRE protocol for remote implementation through participant acceptability ratings, adherence, exertion levels, and safety outcomes, (2) evaluating the usability of the Waveband sleep monitoring headband and adherence to night wear schedules, and 3) gather qualitative feedback through semi-structured interviews to understand participant perspectives on protocol design, session completion, and safety. By integrating behavioral theory, participant engagement, and real-world constraints, this research will inform scalable, home-based interventions that are both effective and responsive to the lived experiences of PwP. The findings will lay the groundwork for future clinical trials and broader dissemination of remote therapeutic strategies in neurodegenerative care.

SwallowFIT Study in Parkinson's Disease

The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease. The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study. Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment. Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.

Multidimensional Assessment of Fatigability in Older Adults Living in Southern Switzerland and Elderly With Parkinson's Disease

With our study, the investigators aim to assess the impact of the fatigue experienced during daily life activities (tiredness) and whether there is a relationship with muscle fatigue during an exercise task. The results of this study may be used to improve the assessment of fatigue in older adults and enhance clinical management. 1. General information An increase in fatigue is considered one of the main causes of reduced quality of life in older adults and in people suffering from chronic diseases. However, the investigators still know little about the mechanisms underlying fatigue in older adults, mainly because most of the available tools were developed to assess this symptom in younger populations with specific diseases, without proper adjustments for physical activity or age. In 2015, the Pittsburgh Fatigability Scale (PFS) was developed as a self-administered questionnaire to assess both physical and mental fatigue in older adults. The PFS consists of 10 questions describing activities of varying duration and intensity. The other scale the investigators will ask participants to complete is called the Fatigue Severity Scale (FSS): a 9-item questionnaire that evaluates fatigue intensity in various situations over the past week. Participants' fatigue will also be assessed during two motor tasks simulating daily activities: a handgrip test and a seated leg exercise mimicking walking. If participants decide to take part in our research project, participants will complete the PFS and FSS questionnaires once (5-10 minutes) and perform two brief motor exercises to determine the onset and progression of muscle fatigue. The exercises will last about 20 minutes, with an additional 10 minutes for preparation. Each contraction will last a maximum of 2 minutes. The project will last 12 months (Swiss section) and will be conducted at \[(1) the nursing homes of the Multistruttura di Bellinzona, the Fondazione Parco San Rocco facilities in Morbio Inferiore and Coldrerio, and the Opera Charitas nursing home in Sonvico\] (period: December 2024 - May 2025); and (2) at the \[San Raffaele University Research Institute\] in Milan, Italy, where 40 older adults with Parkinson's disease will participate (September 2026 - March 2027). This research project is conducted in accordance with Swiss legislation and current international ethical guidelines. It has been reviewed and approved by the Ethics Committee of the Canton of Ticino. 2. Study procedure The testing session will last a maximum of 30 minutes and will include the following steps: Discussion of the study procedures. Verification of appropriate leg clothing. The exercise can be performed either by wearing shorts or by rolling up long trousers to expose the upper half of the thigh. Review of the completed Pittsburgh Fatigability Scale (PFS) questionnaire and completion of the Fatigue Severity Scale (FSS), both available in Italian. Performance of two motor exercises (a surrogate walking test and a handgrip test). 1. First, participants will be instructed on how to perform the surrogate walking test, which evaluates leg muscle fatigue. During the exercise, participants will push with their legs and foot on a movable platform that slides along rails within the device. The sliding motion is resisted by elastic bands that stretch and shorten as participants push. The exercise will be repeated for several cycles until participants are told to stop. To measure muscle fatigue, surface electrodes (non-invasive) will be placed on the skin over two thigh muscles. 2. After a 5-minute rest, participants will be asked to perform the handgrip test with participants' right hand (see Figure 3). The maximal handgrip test will be performed while seated, with participants' forearm resting on a table. The test will be repeated several times until participants are instructed to stop.

Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease

This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either 12-week multi-strain probiotic treatment or placebo.

TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields. This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.

Multicontext Approach for Cognitive Function in Parkinson Disease

Mild cognitive decline is common in early Parkinson disease (PD) and is associated with disability, reduced quality of life (QOL), and increased risk for dementia. Medical treatments for PD do not prevent or treat cognitive decline and may even exacerbate the problem. Unfortunately, existing cognitive interventions for PD, which focus on restoring deficient cognitive skills through cognitive training (repetitive practice of tasks that challenge specific cognitive skills), provide limited benefit for daily function and QOL. To overcome this limitation, the investigators use strategy training. the investigators help people develop targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish daily activities. Contemporary cognitive rehabilitation evidence supports strategy training for other neurological conditions and mild cognitive impairment (MCI), but it has not been well-studied in PD. By teaching strategies for everyday cognition, the investigators hypothesize that our interventions will improve functional outcomes for people with PD. Study participants will complete a baseline cognitive testing session, 10 cognitive treatment sessions with a trained occupational therapist, then have follow-up visits with the study team at 1-week, 3-months, 6-months, and 12-months after completing the study intervention.

Brief Title: Aerobic Training on Cerebrovascular Function, Cognition and Gait in Parkinson's Disease

This randomized controlled trial will investigate the effects of a 12-week supervised aerobic training program on cerebrovascular function, peripheral vascular health, cardiovascular autonomic modulation, cognition, non-motor symptoms, sleep, mood, gait biomechanics, quality of life, and body composition in patients with Parkinson's disease (Hoehn \& Yahr stages 1-3). Participants will be randomly allocated to aerobic training or usual care.

Whole-Body Vibration Exercise in Patients With Parkinson's Disease

This study is a prospective, single-blind, randomized controlled trial designed to investigate the effects of whole-body vibration (WBV) exercise on balance, mobility, fall risk, and proprioception in patients with Parkinson's disease. A total of 68 patients diagnosed with Parkinson's disease, aged between 50 and 75 years, will be recruited from the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Istanbul University, Istanbul Faculty of Medicine. Eligible participants will be clinically stable (no medication changes within the last 3 months), classified as Hoehn and Yahr stage 1-3, and MDS-UPDRS stage 2-3. Written informed consent will be obtained from all participants before enrollment. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (n=34) or the control group (n=34). Randomization will be performed using a computer-generated random allocation sequence. Outcome assessments will be conducted by a blinded assessor. The intervention group will receive whole-body vibration (WBV) training in addition to a standardized home exercise program. WBV sessions will be performed using the Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA). Training will be conducted three times per week for 8 weeks (24 sessions total). Each session will include 5 sets of vibration exposure, consisting of 1 minute of vibration followed by 1 minute of rest. Exercises will be performed in semi-squat and lunge positions. Vibration parameters will be set at 6 Hz frequency with 2-4 mm amplitude. Sessions will be scheduled during the "on" phase of dopaminergic medication. Each session will include a 10-minute warm-up and a 5-minute cool-down period. The control group will perform only the standardized home exercise program. Both groups will receive initial in-clinic instruction for the home exercise program, which includes posture exercises, breathing and relaxation exercises, lower extremity active range-of-motion exercises, stretching, quadriceps strengthening, terminal knee extension exercises, rhythmic gait training, and balance/coordination/proprioceptive exercises. Home exercises will be performed three times per week for 8 weeks, lasting 30-45 minutes per session. Participants will be contacted weekly to monitor adherence. Outcome assessments will be conducted at baseline, at 8 weeks (post-intervention), and at 16 weeks (follow-up). The primary outcome measure is the Berg Balance Scale (BBS). Secondary outcome measures include: * Timed Up and Go (TUG) test * Six-Minute Walk Test (6MWT) * Fall Risk Index measured by computerized static posturography (TETRAX®) * Knee joint position sense measured using an isokinetic dynamometer (Biodex System 3 Pro), calculated as absolute angular error The primary analysis will evaluate changes in BBS scores between groups across time points using repeated measures analysis of variance. Secondary outcomes will be analyzed using similar statistical methods. Statistical significance will be set at p \< 0.05. The study aims to determine whether WBV combined with a home exercise program provides superior improvements in balance, mobility, fall risk, and proprioception compared with a home exercise program alone in individuals with Parkinson's disease.

Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.

In recent decades, advances in medicine have significantly improved both quality of life and life expectancy. However, these positive effects are also associated with a considerable increase in the prevalence of age-related diseases. Among these, Alzheimer's disease (AD), Parkinson's disease (PD), and type 2 diabetes (T2D) currently represent a major threat to human health. PD and AD are the most common neurodegenerative diseases in industrialized populations. In particular, AD accounts for 54% of all cases of dementia, with a prevalence of 4.4% among individuals over 65 years of age. PD has a prevalence of about 1% in people older than 60 years, reaching up to 4% in those over 80 years of age. AD and PD are highly disabling disorders with a slow but progressive course, caused by the degeneration and/or death of nerve cells. This results in impairments in the control of movement and balance, as in the case of PD, or in cognitive functioning, as in AD. To date, neither effective treatments nor early diagnostic tools are available to address these conditions in the initial phase of neurodegeneration. Likewise, there are no tools capable of monitoring disease progression and improving patients' adaptation to therapy. Moreover, although the association between T2D and the risk of PD and/or AD has long been recognized, these conditions were historically considered unrelated. Recent evidence from clinical and epidemiological studies suggests the existence of shared pathophysiological mechanisms associated with insulin resistance and persistent inflammation in several metabolically relevant tissues, such as adipose tissue and the brain. However, the mechanisms that increase the risk of PD and/or AD in individuals with T2D remain poorly understood. These data highlight how relevant these diseases are for the National Health System and demonstrate that they represent one of the most important priorities to be addressed, requiring substantial investments in both scientific research and early diagnostic strategies. Therefore, the present project proposal, which aims to develop new minimally invasive tools for the early prediction and monitoring of neurodegenerative diseases such as AD and PD, will help fill an important gap in the clinical and therapeutic management of these patients.

Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease

This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the "hyperdopaminergic symptoms" corresponding to section 3 of the "Ardouin Behavioural Scale" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.

Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug). Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.

Auricular Vagus Nerve Stimulation Combined With Rehabilitation in Parkinson's Disease

Parkinson's disease (PD) is a progressive, neurodegenerative movement disorder characterized by a combination of motor and non-motor symptoms. Auricular vagus nerve stimulation (aVNS), one of the physiotherapy methods used in PD, has been shown in studies to have a positive effect on symptoms such as motor symptoms, gait disturbance, freezing, and cognitive impairment, and is considered a safe and feasible method. The aim of this study is to investigate the effects of neurological physiotherapy and rehabilitation, in combination with aVNS application, on balance, gait, and clinical symptoms in individuals with PD.

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.

The Role of Priors in Hallucinatory Perception in Parkinson's Disease

The goal of this observational study is to better understand the mechanisms of hallucinations in patients with Parkinson's disease. The main question it aims to answer is: Do prior expectations increase the rate of false perceptions during a visual stimulus detection task more in Parkinson's disease patients with visual hallucinations compared to those without? Participants will undertake a computer task involving face detection and a battery of neuropsychological tests.

Predictors of Clinical Outcomes of Deep Brain Stimulation in Parkinson's Disease

The goal of this observational study is to identify factors in blood that are associated with response to deep brain stimulation (DBS) surgery in patients with Parkinson's disease. The main questions it aims to answer are: 1. What factors in blood (proteins and RNA) are associated with good vs poor response to DBS? 2. Are these factors able to predict response to DBS? 3. How do these factors change before and after DBS? Blood and leftover brain tissue (which spontaneously adhere to the surgical instruments) will be taken and routine clinical data (including scores from routine assessments) will be collected from consenting participants who undergo DBS.

Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI

Telerehabilitation is a promising tool for treating and preventing further disease progression in Parkinson's disease (PD) \[1, 2\]. First studies in people with PD (PwPD) verified the feasibility of home-based digital cognitive training \[3-7\]. Progression in cognitive impairment and the onset and worsening of problems with complex everyday tasks are hallmarks of the prodromal phase of Parkinson's disease dementia (PDD). Consequently, the risk of PDD conversion is dramatically increased for PwPD with both mild cognitive impairment (PD-MCI) and complex activities of daily living (ADL) problems related to cognitive impairment \[8\]. Therefore, this group may be a promising target group for interventions, as they are at risk for serious and rapidly progressive cognitive deterioration. PwPD with PD-MCI show deficits in motor-cognition \[9\] and attentional-control, both of which affect ADL \[10\]. Dual-task cognitive trainings (DCT) shows great potential to lower down the disease process \[11, 12\], but so far no home-based DCT with the primary endpoint of complex ADL and cognition has been conducted in PwPD. We adapted an on-site DCT to improve both physical and cognitive function in PwPD \[13\]. The training will be conducted as a telerehabilitation training in PwPD with PD-MCI and cognitive ADL impairment, identified with the Functional Activities Questionnaire (FAQ). Of PwPD with PD-MCI who have more cognitive rather than motor associated ADL dysfunction (reflected by a value of the FAQ quotient \> 1.008), nearly 50% develop dementia (PDD) within three years \[8\]. In our single-center randomized, controlled non-pharmacological intervention, 42 PwPD with PD-MCI and FAQ quotient \>1.008 will be assessed with pre-(T0) and post(T1), 6-months (T2) and 12-month follow-up (T3) testing. After 1:1 randomization to either the experimental DCT or the control motor training (CMT), both groups will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. The training is aimed to enhance cognition as well as ADL and to prevent its further decline, with an emphasis on maintaining ADLs in the prodromal stage of Parkinson's disease dementia (PDD).

Short and Long-term Responses of PD Symptoms to Earstim

This is a prospective, multicenter, randomized, two-period study designed to evaluate the safety and effectiveness of the EarStim System for intermittent relief of motor symptoms in patients with Parkinson's disease experiencing wearing-off phenomena. Adult patients with moderate to severe Parkinson's disease (MDS-UPDRS Part III score ≥33) receiving oral dopaminergic therapy will be enrolled. Period A is a randomized, double-blind, sham-controlled phase conducted in a clinical setting. Period B is an unblinded, standard-of-care-controlled phase evaluating the effectiveness of the EarStim System during home use over 90 days.

Assessment of Trunk Control and Postural Instability in Patients With Various Neurological Disorders (Stroke, Parkinson, Sclerosis Multiplex) Using Objective Tools (TecnoBody ProKin Posturometry, 3D Motion Analysis)

Nowadays, stroke is one of the most common leading causes of death in many countries. As the number of stroke patients is increasing, even in younger age groups, there is an increasing need to improve their rehabilitation. In order for this process to start, it is inevitable to integrate the latest recommendations of health and sports science into rehabilitation, in addition to medicine, so that the treatment is as complex as possible. Parkinson's disease is one of the most common neurological diseases, in addition to stroke. The most significant damage can be experienced in motor functions, since one of the main symptoms of the disease is slowed movement, tremor and balance disorders. This postural change can lead to many other musculoskeletal changes, which is why Parkinson's disease is an extremely complex disease that also requires a complex treatment. The third disease examined in our research is multiple sclerosis (MS), which is also one of the most significant nervous system diseases, with nearly 1 million cases registered so far. The most common symptoms of MS patients are weakness, numbness, dizziness, coordination and balance disorders, as well as changes and uncertainty in the gait pattern. One of the essential foundations of rehabilitation after neurological diseases is neurorehabilitation, since the process will only be truly effective if cognitive and motor functions are developed in parallel. In the case of neurological diseases, as we can see above, one of the most significant symptoms is coordination and balance disorders. When the nervous system is affected, trunk control and the patient's posture will always change, depending on the given disease and the individual. One of the fundamental goals of rehabilitation should be to develop stability and postural control, because without these, we will not be able to effectively develop and restore the patients' significant motor functions. This is why it is important that neurological patients are assessed from this perspective as early as possible, so that their treatment plan can be adapted to their disease and themselves as much as possible.

Effects of Vagal Nerve Stimulation on Leg Muscle Activity and Posture in Parkinson's Disease

This study is designed to better understand the mechanisms contributing to impaired activation of leg muscles in people with Parkinson's disease (PD) and to test if stimulation of a nerve at the neck can improve muscle activation, walking and balance.

Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease

This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. The psychometric properties of the translated instrument will be evaluated through a multi-phase process involving translation/back-translation, pre-testing, and large-scale validation across multiple Italian centers

Colonic Tissue Biopsy Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis or REM Sleep Behavior Disorder

The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease or REM Sleep Behavior Disorder (RBD). The main question it aims to answer is: Can doctors find a protein called alpha-synuclein in colon tissue samples from people with Parkinson's disease and RBD? Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems and RBD by loss of muscle atonia during REM sleep, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.

Colonoscopic Detection of Phosphorylated Alpha-synuclein for Parkinson's Diagnosis

The goal of this observational study is to learn whether tissue samples taken from the colon during routine colonoscopy can detect signs of Parkinson's disease. The main question it aims to answer is: Can doctors find a protein called alpha-synuclein in colon tissue samples from people with Parkinson's disease? Currently, Parkinson's disease is diagnosed by observing symptoms like tremors and movement problems, but by then the disease has already progressed significantly. Earlier detection could help doctors start treatment sooner.