Clinical Research Directory

Spinal Cord Stimulation for Children With Cerebral Palsy

The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are: * What are the mechanisms of spinal circuit hyperexcitability in CP? * Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability? Participants with cerebral palsy will be asked to complete: * Movement and strength exercises * Mild, non-invasive stimulation on the back and legs that feels like a light tap. * Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.

The purpose of the study is to assess the safety and efficacy of increasing doses of IPN10200 with the aim to evaluate the Pharmacodynamics (PD) profile of IPN10200 and to establish the total IPN10200 doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.

Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic neurological disease frequently associated with spasticity, which may lead to functional limitations and reduced quality of life. Although spasticity is common in MS, detailed descriptions of upper and lower extremity spasticity patterns are limited. A better understanding of spasticity patterns may help improve individualized rehabilitation and treatment planning. The aim of this study is to classify upper and lower extremity spasticity patterns in patients with multiple sclerosis and to investigate their association with quality of life. Adult patients with MS and clinical spasticity will be recruited from a tertiary care outpatient clinic. Spasticity will be evaluated using the Modified Ashworth Scale, and extremity postures will be recorded to define spasticity patterns. Functional performance will be assessed using the Timed 25-Foot Walk Test and the 9-Hole Peg Test. The impact of spasticity on quality of life will be evaluated using the Patient-Reported Impact of Spasticity Measure (PRISM). This prospective cross-sectional study is designed to provide a systematic description of spasticity patterns in patients with multiple sclerosis and to examine their relationship with functional outcomes and quality of life.

Neurosurgical Outcome Network

The evaluation of neurosurgical outcomes varies from center to center, and the predictive factors that determine these outcomes are not fully known or shared. This study aims to assess outcomes and their predictors using measures agreed upon by the participating centers. Standardizing the evaluation of outcomes and predictors improves the quality of research, allows for data comparison, and facilitates a "common language" in routine clinical practice. Most importantly, it influences therapeutic decisions in various neurosurgical conditions. Clinically, the identified predictors can also be used during preoperative assessments to provide more precise guidance to patients undergoing surgery.

Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury

Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or stretching; medications such as Baclofen; and injections with agents like botulinum toxin (also known as Botox). Botox injections are often implemented alongside other modalities like therapy, yet they are invasive, tend to last for only a few months, and carry potential side effects. One potential non-invasive treatment for upper limb spasticity is focused extracorporeal shockwave therapy (f-ESWT), which involves an external application of high-pressure sound waves, similar to ultrasound. An applicator/handpiece is placed on the skin over the spastic muscle and the focused sound waves are applied. f-ESWT carries no long-term side effects with minimal discomfort during application. However, there has been limited research on this treatment option in people with SCI who have arm and hand dysfunction caused by spasticity. The purpose of this study is to fill in that knowledge gap. This will be accomplished by measuring different aspects of spasticity from the perspective of both the clinician and the person with SCI. These will include clinical measures, such as elbow and wrist range of motion, as well as how the treatment impacts the person's functional independence and quality of life. Ultrasound methods will be used to look at the person's muscles to see if any beneficial changes occur in their structure and stiffness. People with SCI who meet eligibility criteria will be invited to the laboratory to receive f-ESWT, which will occur once per week for three consecutive weeks. Treatment will entail application of f-ESWT to the elbow and wrist flexor muscles. Participants will be invited back to the laboratory to have their spasticity measured by a clinician, be asked questions about how their spasticity has impacted their lives, and have their muscles imaged with ultrasound. Findings from this study are expected to generate insight on whether f-ESWT could be a viable treatment option for spasticity of the arms and hands in people with SCI, and if a larger clinical trial is warranted.

Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment

This trial is part of the spastiCRYO clinical research project. The primary objective of this clinical trial is to test the hypothesis: "Upper limb nerve cryoneurolysis is non inferior to the usual care and has therapeutic add value in dealing with shoulder pain and functional problems caused by spasticity and motor impairment". It is a non-inferiority study on the referred topic, comparing the therapeutic effect (improvement in function and pain) of cryoneurolysis of selected nerves (lateral pectoral nerve and thoracodorsal nerve) with the usual care: intramuscular botulinum neurotoxin type A (BoNT-A) injection of pectoralis major, teres major and subscapularis muscles. The hypothesis is that cryoneurolysis is not inferior to the usual care in terms of magnitude of the therapeutic effect and might have a therapeutic add-value in terms of duration of that effect. Two secondary hypotheses are firstly, that cryoneurolysis is a safe procedure that can be deployed in a rehabilitation hospital setting with minimum requirements to perform mini-invasive procedures and secondly that selecting patients who might benefit from this treatment is straightforward. To test these hypotheses, the research team will gather, analyse and compare outcome measures data from the endpoints which are the changes along the trial duration in shoulder pain, upper limb function, involved muscles spasticity, shoulder range of motion (abduction and external rotation) level of impairment, and follow-up of potential adverse effects in two independent and equivalent groups of participants who have shoulder pain and functional limitations caused by spasticity and are in a stable phase of their condition. Participants in one group (cryoneurolysis arm) have one session of selected nerves ultrasound and neurostimulation guided cryoneurolysis and participants in the other group (BoNT-A arm) have one session of ultrasound and neurostimulation guided injection of BoNT-A in the pectoralis major, teres major and subscapularis. The participants of the two groups follow an upper limb analogous rehabilitation program for 24 weeks after each intervention. Longitudinal follow-up in the trial will take 24 weeks. In a real-world scenario, within 24 weeks the effect of Bont-A intramuscular injection has already waned, and the procedure should be repeated. Secondary objectives are to compare changes in upper limb sensory function and electroneuromyographic parameters with the intention to understand the cryoneurolysis mechanism of action and the reversibility of this mini-invasive intervention. Changes in quality-of-life dimension of participants is a secondary endpoint as well.

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

Effects Of Spiral Strapping Systems On Upper Limb Function In Unilateral Spastic Cerebral Palsy

The purpose of this clinical study is to learn whether two different spiral strapping systems can improve arm and hand use in children with unilateral spastic cerebral palsy. These strapping systems are used to support the arm in a more functional position and to help children control their movements during daily activities. This study aims to answer the following main questions: Does spiral strapping help children use their arm and hand more effectively in daily activities? Does spiral strapping improve hand skills and grip strength? Is there a difference in effect between the two spiral strapping systems? To answer these questions, researchers will divide participants into three groups. One group will receive a standard rehabilitation program plus TheraTogs® spiral strapping. A second group will receive the same rehabilitation program plus TogRite™ spiral strapping. The third group will receive the rehabilitation program only. Participants will: Take part in rehabilitation sessions twice a week for eight weeks. Use spiral strapping during some sessions, depending on their group. Complete arm and hand assessments at the beginning and at the end of the study. The results of this study may help develop simple and practical rehabilitation approaches that support children with cerebral palsy in becoming more independent in daily life.

At Home Use of Stimulation Suits for Managing MS Symptoms

This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning. Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks? Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit). Participants in the intervention group will: * Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home). * Receive their usual care in addition to wearing the suit. * Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation. Participants in the control group will: * Receive their usual care. * Undergo clincial tests at the same time points as the other group.

Effects of Low-level Laser Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Plantar Flexors

Stroke is one of the leading causes of long-term disability worldwide. Many patients who survive a stroke experience muscle stiffness (called spasticity), especially in the ankle and foot muscles, which makes walking difficult and painful. Spasticity in the plantar flexor muscles those that help push the foot down can lead to poor balance, limited mobility, and increased risk of falls. This study aims to explore the effects of low-level laser therapy (LLLT) on spasticity and walking ability in patients who have had a stroke for more than six months (chronic stroke). LLLT is a non-invasive, painless treatment that uses low-intensity light to stimulate tissue healing, reduce muscle tightness, and improve nerve function. A total of 18 chronic stroke patients with spastic plantar flexors were included in this randomized controlled trial (RCT). Participants were randomly assigned to one of two groups: Study group: Received low-level laser therapy along with conventional physiotherapy. Control group: Received conventional physiotherapy alone. Each patient received therapy for three weeks. The study evaluated outcomes using the Modified Ashworth Scale (MAS) for muscle spasticity, the Wisconsin Gait Scale (WGS) for walking quality, and a Goniometer for ankle joint range of motion. Assessments were done before and after treatment. The results showed that both groups improved significantly, but patients who received laser therapy demonstrated greater reduction in spasticity and better gait performance compared to those who received conventional therapy alone. This study suggests that low-level laser therapy can be a useful addition to conventional rehabilitation programs for improving walking ability and reducing spasticity in stroke patients.

Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders and Spasticity

The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain and spasticity. It is structured as a prospective, multi-cohort observational study. Purpose of the Study: The overarching purpose of the CRYONIC PROTOCOL study is to assess the Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders and Spasticity. The study focuses on evaluating the effectiveness of ultrasound-guided peripheral nerve cryoneurolysis, a minimally invasive technique that uses extreme cold to induce temporary nerve blocks, for patients with treatment-resistant chronic musculoskeletal pain and spasticity. The study also seeks to determine if cryoneurolysis itself leads to meaningful improvements in both pain intensity and functional ability in the included patient cohorts (those with chronic musculoskeletal pain or spasticity)

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.

Effectiveness of an Interprofessional Approach to the Treatment of Spasticity With Botulinum Toxin & Non-pharmacological Therapies

Many people with neurological conditions will experience spasticity, a nonvolitional and uncontrollable tightening and/or spasm of muscles. This can impact the person's functioning and independence in everyday tasks and can contribute to contractures. Spasticity and contracture develop and affect each person differently. Treatment is provided by a multi-disciplinary team (MDT), working collaboratively to offer the best combination of medications (including botulinum neurotoxin (BoNT)) and non-pharmacological interventions. There are a wide range of therapy interventions available. Each person's treatment plan is uniquely tailored to them, their individual presentation, and their treatment goals. Evidencing the effectiveness of spasticity and contracture treatment has been difficult. The manifestation and treatment of spasticity is never the same between patients. The experience of the condition and the perceived and observable effectiveness of treatment are unique to the individual. Treatment is most effective when MDT's work together to combine the most appropriate medications and therapies in a treatment plan individualised to the person and their presentation. Understanding how expert teams formulate spasticity treatment and how effectively their expertise influences spasticity outcomes could help inform practice. The purpose of this multicenter, case study series is to evaluate the effectiveness of two conceptually similar, specialised MDT approaches for the treatment of patients with spasticity in two cross-national neurorehabilitation facilities. The goal of this study is to investigate the effectiveness of interprofessional treatments of non-drug interventions in combination with botulinum toxin injections in patients who suffer from spasticity. The main goals of the study are to evaluate: 1. Describe and evaluate the types of botulinum toxin and therapy treatment choices expert MDTs make when treating people with spasticity. 2. Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions is effective at achieving patient goals. 3. Evaluate whether a MDT approach to the assessment and treatment of spasticity using BoNT and non-pharmacological interventions, improves impairment and activity/participation outcomes using commonly used clinical outcome measures. There will be no comparison group. The N-of-1, ABC study design allows participants to serve as their own controls. Participants will undergo assessements to describe their goals and severity of spasticity: * Goal Attainment Scale light * ArmA \& SQoL-6D * LegA * Modified Ashworth Scale * Modifies Tardieu Scale * Muscle Strength according to MRC * Pain Measurement (NRS, VAS or other)

Predictors of Motor İmagery Performance in Cerebral Palsy

There are very few studies in the literature examining the effect of age on motor imagery ability in children with cerebral palsy. To our knowledge, no studies have investigated the impact of other related factors. The aim of this study is to investigate the effects of age, sex, body mass index, Gross Motor Function Classification System (GMFCS) level, and Manual Ability Classification System (MACS) level on motor imagery abilities in children with cerebral palsy. H1-1: Age has an effect on motor imagery abilities in children with cerebral palsy. H1-2: Sex has an effect on motor imagery abilities in children with cerebral palsy. H1-3: Clinical type has an effect on motor imagery abilities in children with cerebral palsy. H1-4: Body mass index has an effect on motor imagery abilities in children with cerebral palsy. H1-5: GMFCS level has an effect on motor imagery abilities in children with cerebral palsy. H1-6: MACS level has an effect on motor imagery abilities in children with cerebral palsy.

Dry Needling in Multiple Sclerosis

The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.

Neuroimmunology Registry and Biobank

A variety of antineuronal antibodies have been detected in the cerebrospinal fluid (CSF) of patients with neurological diseases. This raises the question of whether these antibodies are disease-specific or merely an epiphenomenon of inflammatory processes in the brain. The registry was established with the following objectives: \[1\] Are antineuronal antibodies much more common than previously thought in various neurological disorders for which the etiology has not yet been elucidated? \[2\] Can further correlations, such as those between HSV infection and NMDA receptor autoimmunity, be identified? \[3\] Are these antibodies mainly non-specific epiphenomena or are they crucial for the pathogenesis? \[4\] What is the clinical course of patients with antineuronal antibodies and their response to therapy? These questions will be addressed in a broad immunohistological screening of a large number of CSF samples and a clinical database of patients with neurological disorders.

Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients

Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.

Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management

The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are: Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages. Participants will: Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks. Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement. Complete quality-of-life questionnaires to measure the therapy's impact on daily living.

Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence

This study examines the early use of botulinum toxin in patients recovering from their first stroke to help reduce muscle stiffness and improve mobility. Spasticity, a condition that causes abnormal muscle tightness, is a common complication following strokes. It can result in decreased independence, pain, joint contractures, and difficulty performing daily activities. Early intervention is critical to prevent long-term complications and improve recovery outcomes.The participants are men and women aged 18 and older who have recently experienced their first stroke. These patients, admitted to the Regional General Hospital No. 1 "Lic. Ignacio García Téllez" in Mérida, Yucatán, will receive botulinum toxin injections alongside a comprehensive rehabilitation program. Botulinum toxin, commonly known for its muscle-relaxing effects, will be administered within the first three months after the stroke. This early timeline aims to maximize recovery by addressing muscle tightness before it worsens.The study will evaluate how the combination of botulinum toxin and physical therapy affects muscle tone, functional independence, and overall quality of life. Key measurements include the Modified Ashworth Scale (MAS) to assess muscle stiffness, the Barthel Index to evaluate daily activity independence, and cognitive assessments to monitor brain recovery. Patients' progress will be tracked over several months to measure the intervention's short, medium, and long-term impact.Previous research suggests that early application of botulinum toxin can prevent long-lasting muscle contractures and improve mobility, but more studies are needed to confirm its benefits in stroke rehabilitation. The results of this research could help establish early botulinum toxin injections as a standard practice in stroke recovery programs, reducing disability and healthcare costs while improving the lives of stroke survivors.

Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus

Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.

Ultrasonograpy in Hemiplegic Patients

The aim of this study was to evaluate the architectural changes and muscle stiffness of the upper and lower extremity muscles in our hemiplegic patients ultrasonographically and to investigate their relationship with clinical assessment scales.

Additional Effects of Kinesio-Taping Along with Conservative Physical Therapy on Upper Limb Function, Range of Motion and Spasticity in the Patients with Subacute Stroke

A randomized control trial will be done on diagnosed stroke patients of subacute stage in Fauji Foundation Hospital Rawalpindi and leading edge physical therapy and rehabilitation clinic.The purpose of the study is to determine Additional Effects of Kinesio-Taping along with conservative Physical Therapy on upper limb function, Range of motion and Spasticity in the patients with Subacute Stroke. The conservational physical therapy includes Passive and active ROMs 25 repetitions each, 3 times per week. PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week. D1 flexion and extension for 20 repetitions 3 times per week. Kinesio tape 3 times per week. (Anchor opposed to effected compartment to provide facilitation and sustained stretch). with srtrngth training included in week 3-6 with a resistance band of medium resistance. treatment time will be 30 minutes on alternate days for six weeks.

Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting

The purpose of the study is to measure the outcomes of a standard care, an ultrasound guided mini-invasive percutaneous procedure, performed on recent stroke patients on reduces pain, increases function \& quality of life The primary objective of the project is to reduce shoulder and/or knee pain in patients who have had a stroke so that they can more readily engage in rehabilitation. Secondary objectives are to reduce analgesic medications, increase independence and improve range of motion, to promote non-drug treatment measures in the medical toolkit, and to include an interdisciplinary care team in patient selection for interventions.

Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy

The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS) causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing spasticity and the spastic syndrome in selected cases of patients with cerebral palsy