Clinical Research Directory

A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

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.

Optimistic and Pessimistic Dopamine Signals in the Human Brain: a Mapping and Modelling Study in Health and Parkinson's Disease

The goal of this observational study is to investigate whether the healthy human brain shows a diversity of optimistic and pessimistic reward signals and whether changes in this distribution in Parkinson's disease (PD) can provide mechanistic insights into the cause of symptoms. The main hypotheses it aims to test are: 1. As shown in mice, a diversity of optimistic and pessimistic dopamine reward signals exists in the human ventral tegmental area (VTA) and the ventro-rostral basal ganglia circuit. 2. Pessimistic neurons are more severely affected by neurodegeneration in PD. Researchers will compare the diversity of optimistic and pessimistic dopamine reward signals in patients with PD and healthy participants to see if there is a skewed distribution of optimistic and pessimistic reward signals in PD. Participants will play a task probing reward- and movement related brain activity in an MRI scanner. Researchers will derive functional topographic maps of optimism/pessimism in VTA, substantia nigra pars compacta (SNc), striatum and cortical areas such as the anterior cingulate cortex (ACC). In sub-study 1, participants will be tested on one study day where patients with PD are tested in the off-medication state (40 control participants, 40 patients with PD). In sub-study 2, to test whether/how dopaminergic medication affects the distribution of optimism/pessimism, participants will be tested on two study days (30 control participants, 30 patients with PD). Patients with PD are tested one day in the off-medication state, another day in the on-medication state (order counterbalanced between patients with PD). Control participants are tested on two days without medication challenge to test for test-retest effects.

Comparing Biomarker-Guided DBS Programming With Standard Clinical Monopolar Programming

The goal of this clinical trial is to learn whether an objective, data-guided approach to programming deep brain stimulation (DBS) can improve motor outcomes in people with Parkinson's disease who undergo DBS surgery. The study includes adults aged 30 to 70 years with Parkinson's disease who are candidates for DBS. The main questions it aims to answer are: Does DBS programming based on objective markers (brain imaging and brain signals) reduce the amount of daily time patients spend in the OFF state more than conventional clinical programming? Does this programming approach improve quality of life and motor symptoms compared with standard programming? Researchers will compare conventional DBS programming based on clinical monopolar review with DBS programming guided by electrode location on neuroimaging and beta brain signals recorded from the implanted device, to see if the objective approach leads to better motor control and less OFF time. Participants will: Undergo DBS surgery using a clinically approved DBS system Be randomly assigned to one of two DBS programming strategies Wear inertial sensors at home for several days at different time points to objectively measure motor symptoms Attend scheduled clinical visits for DBS programming and motor and non-motor assessments Have adaptive DBS activated after 3 months and continue follow-up until 6 months after programming begins

Transforming Parkinson's Care With Predictive Algorithms

Lifestyle interventions can alleviate Parkinson's Disease (PD) symptoms and delay disease progression. The novelty of this project lies in the development of an innovative smart platform that utilizes artificial intelligence (AI) and predictive models to offer a groundbreaking solution that not only prevents disease progression but also significantly improves the well-being of patients with PD. For this, the technological smart platform will encompass 50 clinical variables, and a comprehensive range of other 50 supplementary variables, validated in a database with more than 1500 patients. The smart platform will include a user-friendly interface with different user profiles and a scalable back end with AI-based monitoring and prediction modules. This will offer primary prevention, early detection, and ongoing monitoring by specialized medical professionals at home and in hospitals.

Studies of Brain and Body Interaction

The goal of this study is to characterize biophysiolgoical signals as a comprehensive profile of the nervous systems in order to understand interactions between the brain and body, while an individual performs naturalistic behaviors (ex. walking, pointing) and while breathing at a slow controlled pace. The investigators aim to study these interactions among a variety of populations, from healthy individuals to those with disorders such as Autism Spectrum Disorder(s), including those who may also have an ADHD (Attention-deficit/hyperactivity disorder) diagnosis, Asperger's Syndrome, Alzheimer's Disease, and/or Fragile X syndrome

Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's Disease

The goal of this research is to determine (1) the feasibility of tethered capsule OCT esophageal imaging in the Parkinson's Disease population; (2) the morphologic changes in the enteric nervous system of the esophagus in patients with Parkinson's disease.

Which Tools Better Predict Fall Risk in Parkinson's Disease: A Comparative Study of Objective, Self-Reported, and Functional Balance Assessment

Introduction: Falls are common in Parkinson's disease (PD), affecting 30-90% of patients annually, with more than half experiencing recurrent falls. Identifying balance assessment tools that are both practical and predictive of fall risk is therefore essential. This study aimed to investigate the relationship between fall frequency and three balance assessment tools: the Biodex Balance System (objective), the Falls Efficacy Scale-International (FES-I) (self-reported), and the Mini-Balance Evaluation Systems Test (Mini-BESTest) (functional). Methods: Patients with PD at Hoehn and Yahr stages 1-3 will be included in the study. Fall data will be collected using a fall diary, while objective balance will be assessed with the Biodex Balance System, functional performance will be evaluated with the Mini-BESTest, and self-reported balance confidence will be measured with the FES-I.

Neuroplasticity in Parkinson's Disease

The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.

Mediterranean Diet Effects on Parkinson's Disease

Currently, there are no disease-modifying treatments for Parkinson's disease (PD), the second most common neurodegenerative disorder worldwide, making it crucial to find interventions that can change the disease's trajectory. Epidemiological studies suggest that the Mediterranean diet (MD) is linked to improved motor and non-motor symptoms, slower disease progression, and lower mortality in PD patients. However, few interventional studies have explored this connection. This study assesses whether an MD can improve motor and non-motor symptoms in PD patients. Additionally, the study will examine the effects of the diet on a patient's quality of life, gastrointestinal symptomatology, adaptive immune system, fecal and nasal microbiome, and fecal and urinary metabolomics. This is a randomized, controlled, non-pharmacological, single-center, masked trial with two parallel groups. It will evaluate the safety and efficacy of the MD on motor and non-motor symptoms reported by PD patients. Forty-four participants, aged 40-85, meeting the inclusion criteria will be enrolled and block-randomized into two groups: one maintaining their usual diet (control) and the other following a MD for six months (intervention). The primary outcome is patient-reported symptoms, measured using the MDS-UPDRS I+II score. Secondary outcomes include the analysis of adaptive immune system cells, nasal and fecal microbiome composition, and inflammatory and metabolic markers. Additional assessments include disease severity (MDS-UPDRS), non-motor symptoms (Non-Motor Symptoms Scale), participant well-being (36-Item Short Form Health Survey), gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale and Patient Assessment of Constipation Quality of Life), and the intensity of dopaminergic therapy (levodopa equivalents). Evaluations will be performed at baseline and after six months.

Neurologic Stem Cell Treatment Study

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

The Brain&Senses Study

The aim of this longitudinal observational study is to evaluate the impact of sensory deficits (smell, hearing and balance on cognitive decline and quality of life in the medium term (5 years)) on a population of patients over 55. Patients will be evaluated by a neurologist, a neuropsychologist and an otolaryngologist who will perform olfactory, auditory and vestibular tests. The acquired data will then be analyzed with multivariate analysis to understand the effect of multisensory deficit on both cognition and quality of life with a particular focus on depression. The primary objective will be the evaluation of multiple deficits on cognition, the secondary will be aimed at understanding whether one sensory deficit more than another, e.g. smell versus hearing, will have a greater impact on the patient's conditions.

Validity and Reliability of the Standing Up From Supine Test With Parkinson's Patients

In individuals diagnosed with Parkinson's disease, not being able to stand up especially after falling problems and staying in supine position cause loss of motivation and decrease in quality of life for patients. In order to prevent this problem in neurological diseases, it must be evaluated and treated by working functionally as a result of this evaluation. Parkinson's patients who will participate in the study will be referred from SANKO University Sani Konukoğlu Application and Research Hospital Neurology Polyclinic. The evaluations of the patients referred from the neurology polyclinic will be carried out in SANKO University Physiotherapy and Rehabilitation Department Research Laboratory. Socio-demographic information of the included patients will be obtained. Then, the supin to stand test will be used to measure the transition time from the supine position to the standing position and mobility status, the Activity-specific balance safety scale (ABC) for fear of falling, the Berg Balance Scale for balance assessment and the timed get up and walk test, 9-hole peg test for upper extremity functionality, manual muscle testing device for muscle strength of Dorsi flexor and Plantar flexor muscle groups in the ankle, Parkinson's Disease Quality of Life Questionnaire (PHA-39) for quality of life. The evaluations to be applied will be carried out by Dr. Lecturer. Member Hakan Polat will be carried out by Hakan Polat. Apart from the supine to stand test, the other tests to be performed are tests that evaluate the parameters that an individual should have for the transition from supine to standing position. These parameters are balance, muscle strength, ability to stand up without sitting, fine motor skill ability. Supin to stand test will be re-evaluated by a different physiotherapist in SANKO University Physiotherapy and Rehabilitation Department Research Laboratory after 1 week.

Posture Exercises in Parkinson's Disease

The research was planned as a quasi-experimental study to investigate the effects of postural exercises on body image and neck and trunk position sense in Parkinson's patients. It was decided to conduct the study with Parkinson's patients over the age of 50 who applied to the neurology clinic. After the power analysis for the research, it was planned to reach 36 participants. Participants' consent to participate in the study will be obtained through the Informed Volunteer Consent Form prepared by the researchers. Demographic information of participants who consent to participate in the study will be collected. Then, the disease levels and severity of the participants will be determined using the Modified Hoehn Yahr Staging Scale and the Unified Parkinson's Disease Assessment Scale. Subjective Visual Vertical Perception, Subjective Postural Perception and Subjective Haptic Perception evaluations to evaluate the body image of patients; Clinometer application and neck and trunk proprioception evaluations will be applied as preliminary tests to evaluate neck and trunk position sense. Posture exercises planned by the researchers will be applied to the participants, whose pre-tests are completed, three days a week for eight weeks. Preliminary tests performed after eight weeks of exercise will be repeated. All data obtained will be recorded in the Participant Data Record form. Differences in changes in tests performed at eight-week intervals will be investigated with appropriate statistical methods.

Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application

The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is: * Is there a biomarkers that allows the identification of PD from healthy controls? * Is there a biomarkers that can identify the severity of the disease? * Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease? Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.

Virtual Reality and Fear of Falling in Parkinson's Disease

Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. The fear of falling (FoF), a natural response to unstable balance, can exacerbate postural control problems. However, evaluating FoF relies primarily on subjective self-reports due to a lack of objective assessment methods. Objectives: This mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. This protocol examines a range of FoF-related responses, including cognitive, neuromuscular, and postural stability factors. Methods: Individuals without and with Parkinson's disease will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where FoF can be elicited using virtual reality (VR) technology. Data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. Semi-structured interviews will gather participants' and researchers' experiences of the protocol. Discussion: This method may allow accurate assessment of how FoF impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. Virtual environments reproduce real-life scenarios that trigger FoF. Rigorously assessing FoF with this approach could demonstrate its ability to quantify the effects of FoF on movement. Conclusions: This protocol aims to improve FoF assessment by evaluating multiple responses during movement in virtual environments. It addresses current measures' limitations. A feasibility study will identify areas for improvement specific to Parkinson's disease. Successful validation could transform how FoF is evaluated and managed.