Clinical Research Directory

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.

Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury

Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.

Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia

Spinal cord injury (SCI)-related paraplegia is a complex neurological condition characterized by motor impairment, increased spasticity, and significant functional limitations in daily activities. Spasticity is one of the most common secondary complications after upper motor neuron lesions and can negatively affect rehabilitation outcomes, gait ability, and functional independence. This randomized controlled study aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Brief Summary This randomized controlled trial aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Individuals included in the study will be divided into three groups: control group, FES application group, and Sham group. The control group will receive only a standard neurological rehabilitation program, while the FES group will receive Functional Electrical Stimulation to the quadriceps muscle in addition to the FES program. The Sham FES group will receive Conventional neurorehabilitation + sham/placebo FES. The primary outcomes include changes in spasticity level, quadriceps muscle strength, and functional mobility. Spasticity will be assessed using the Modified Ashworth Scale (MAS), muscle strength will be evaluated with Manual Muscle Testing (MMT), and functional mobility will be measured using the Spinal Cord Independence Measure (SCIM), Timed Up and Go Test (TUG), and 6-Minute Walk Test (6MWT). The intervention period will last 8 weeks, with standardized rehabilitation programs applied to both groups. The FES group will additionally receive quadriceps stimulation with specific neuromuscular electrical stimulation parameters. The findings of this study are expected to provide evidence regarding the effectiveness of FES as an adjunct to conventional rehabilitation in improving motor function and functional independence in individuals with paraplegia.

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.

Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation

The purpose of this study is to investigate treating severe spasticity in persons with spinal cord injury by implanting a device in the body that delivers electrical stimulation around the spinal cord (spinal cord epidural stimulation). This study will be closely monitoring a program designed to treat spasticity using an epidural stimulator to better understand its effects on spasticity and voluntary movement.

Co-contraction and Corticoreticular Excitability in Spinal Cord Injury

This study is to elucidate whether hyperexcitability of the cortico-reticulospinal tract leads to abnormal co-contraction and spasticity of elbow flexors in persons with cervical cervical spinal cord injury. By measuring the supplementary motor area (SMA) regulation of the StartReact response, it is possible to quantify whether the cortico-reticular pathway is excessively active or weakened in these persons. Participants will 1. Be assessed for upper limb function 2. Receive motor evoked potential of tested biceps muscle 3. Receive a standard StartReact paradigm to measure the reticulospinal excitability. 4. Received a conditioning-test paradigm to assess corticoreticular excitability. 5. Conduct a sustained isometric elbow extension task

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.

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.

The Use of Photobiomodulation in the Treatment of Spasticity After Stroke.

Stroke is a non-progressive and permanent syndrome in adults, with approximately 60% of patients presenting with spastic hemiparesis. Spasticity leads to changes in the physiological pattern of muscle tissue contraction and hemodynamics, and, when left untreated, negatively impacts functionality. Photobiomodulation (PBM) has demonstrated positive effects on tissue regeneration, muscle relaxation, reduction of inflammation, fatigue, and pain relief in various muscular and neurological disorders. Methods: This blinded, randomized, controlled clinical trial aims to evaluate the effects of PBM on triceps surae muscle spasticity in adults with stroke. Forty-two participants with spastic hemiparesis post-stroke will be randomized into two groups: active PBM (850 nm, 200 mW, 4 J/point in the gastrocnemius, 12 points, weekly for 8 weeks) or placebo PBM (same protocol, device switched off). Both groups will receive the institute's standard rehabilitation treatment. Outcomes will be assessed using the Modified Ashworth Scale (MAS), ankle range of motion, presence of pain, amount of antispastic medication in use, contraction strength (by manual examination) muscle oxygenation (by transcutaneous near-infrared spectroscopy), functionality, and the occurrence of adverse events before and after the intervention. At the end of recruitment, comparisons between groups and between time points will be performed and statistically analyzed using a two-way repeated means ANOVA test and the Generalized Estimating Equations (GEE) test. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.

Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity

Muscle stiffness and muscle spasms are common after spinal cord injury. They can interfere with washing and dressing, moving between the bed and a wheelchair, walking, and sleep, and they can cause pain. Oral medications are the usual first-line treatment, but many people report limited benefit or side effects. This study examines a non-surgical method called transcutaneous spinal stimulation. Surface electrodes are placed on the lower back and on the abdomen, and an electrical current is passed between them to activate nerve fibers entering the spinal cord. Adults who have had a spinal cord injury and have muscle stiffness or spasms in the legs may participate. Each participant takes part in all parts of the study and serves as their own comparison. Participants attend four visits at one study site, about one week apart. The first visit is for consent and a clinical examination. At each of the next three visits, the participant receives one capsule containing tizanidine, baclofen, or an inactive substance (placebo), in an order assigned by chance. One hour later, the participant receives two 15-minute periods of spinal stimulation, one at 30 pulses per second and one at 75 pulses per second, also in an order assigned by chance. Neither the participant nor the person conducting the testing knows which capsule was taken. Leg reflexes, muscle activity, and knee movement are measured before the capsule is taken, one hour after it is taken, during each period of stimulation, and after each period of stimulation. Clinical scales for stiffness and spasms are also scored. The study compares the two stimulation rates, compares stimulation with each medicine given alone, and examines whether adding stimulation to a medicine has a larger effect than stimulation alone.

Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain

To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.

Dorsal Root Electrical Stimulation in Children With Cerebral Palsy

The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).

Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy

Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated. OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico. Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.

Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

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 Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total Corabotase doses(s) that offer the best efficacy/safety profile when used for the treatment of Adult upper limb (AUL) spasticity.

Multicenter Study of Thermal Radiofrequency Applied to the Musculocutaneous Nerve for the Treatment of Spasticity

This multicenter observational study evaluates the safety and effectiveness of ultrasound-guided thermal radiofrequency applied to the musculocutaneous nerve in adult patients with focal elbow flexor spasticity secondary to central nervous system injury. Hypothesis: Thermal radiofrequency treatment of the musculocutaneous nerve in patients with spasticity resulting from damage to the central nervous system is a safe and effective treatment for spasticity.

Collagenase Injection for Spasticity Management

The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for spasticity management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of upper limb spasticity in adults followed by an open-label extension safety trial.

Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity

Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension safety trial.

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.

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.

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.

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

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