- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06893653
Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
Combined Effects of Focal Muscle Vibration and tDCS on Motor Recovery in Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A stroke is a medical condition characterized by a sudden, localized, loss of neurological function resulting from damage to the blood vessels in the central nervous system. It is a prevalent condition globally and leading cause of disability impairing motor function and significantly impact daily activities and work. 26% of individuals with stroke have a disability in ADLS and 50% have motor impairment gait disorder contribute to 20 to 30%. Spasticity 25%-40% which ultimately affect the quality of life of patients.
Spasticity arises from central nervous system damage where the loss of cortical neurons reduces descending inhibitory control over the spinal cord, affecting the balance between inhibitory and excitatory inputs leading to disinhibition of spinal reflexes causing hyperexcitability of stretch reflexes increase H reflex activity and impaired reciprocal inhibition.Fastest city interacts with weakness resulting in disabling motor impairments and complex complication like muscle contractor motor dysfunction and plastic paint which negatively impacts on patients quality of life.
Noninvasive brain stimulation (NIBS) has been seen more common in rehabilitation setting as an add on therapy to conventional rehabilitative treatment. The main goal of NIBS is to create neuromodulation by inhibiting or activating neural activity in the targeted cortical region. There are different modalities used for NIBS most widely used are transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). tDCS involves a small current to the scalp aiming to modulate cortical excitability. Typical configuration of tDCS are the anode electrode place over the brain area of interest aiming to increase excitation and the cathode electrode placed as a reference, over contra lesional hemisphere aiming to decrease excitability and all electrode taste as a reference such as if she does not supra orbital region. In stroke recovery tDCS is often used to either enhance excitability in the lesioned hemisphere or suppress in the non-lesioned hemisphere to rebalance neural activity. The core concept of tDCS is operating on a simple principle, i.e. the positive terminal of the battery also referred to as the anode is connected to one special location on the head and the negative terminal or cathode is attached at the other end of the head. An electromotive force is generated between these two contact points on the head that creates a potential difference. This difference push positively charged ions that are potassium, sodium and calcium away from the anode towards the cathode this when way neurons that are located under the anode get a boost for excitation and at the same time inhibition occurs at the cathode and that's how whole brain activity is modulated.
Another intervention strategy that has potential for sustainable stroke rehabilitation is the use of mechanical vibration as a therapeutic intervention known as vibration therapy. Focal vibration (FV) reduces muscles spasticity, facilitate muscle contraction and stimulates the proper system to obtain efficient motor control during functional activities. In FV, mechanical vibrations are applied to localized muscles generally the muscle belly or the tendon on the affected side. The suggested mechanism of action of focal vibration on spasticity is depression of the H-reflex within the spinal motor neuron and reciprocal inhibition between the agonist and antagonist muscles.
A study was done aimed to assist the current evidence on the effect of tDCS on upper limb motor function and identified evidence suggest that tDCS has a superior effect in improving function of upper lamp in patient who had a stroke. In 2019, meta-analysis was done to explore the effect of tDCS on different stages of stroke (acute, sub-acute, chronic) and result show that tDCS had a significant effect in the patient of chronic group. Stronger connectivity of ipsilesional and the parietal cortex and contra lesional frontotemporal cortex was found to be associated with an increase in cortico spinal excitability following the anodal tDCS in chronic stroke survivors. A meta-analysis of multiple session reviewed how tDCS parameters influence upper limb function and demonstrate that tDCS applied during therapy yield significant results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab Province
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Rawalpindi, Punjab Province, Pakistan
- Pakistan Railway Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic stroke
- Spasticity > 1 at Modified Ashworth Scale.
- FMA score more than 36
Exclusion Criteria:
- Metallic implant including shunt, intracranial pacemaker, surgical clip etc.
- Any neurological disorder other than stroke
- Any Orthopedic impairment that limit the motor recovery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: FMV
FMV + PT
|
FMV will be applied to the muscle belly along with the conventional physical therapy
Conventional physical therapy will be provided
|
|
Active Comparator: tDCS
tDCS + PT
|
Conventional physical therapy will be provided
tDCS will be applied to M1 area of brain along with the conventional physical therapy
|
|
Active Comparator: FMV & tDCS
FMV + tDCS + PT
|
Conventional physical therapy will be provided
Focal muscle vibration with tDCS and conventional physical therapy will be provided.
|
|
Active Comparator: PT
PT only
|
Conventional physical therapy will be provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl Meyr Assessment
Time Frame: 20th week
|
FMA is used for the assessment of physical performance and sensorimotor function of neurological patients.
It uses a 3-point ordinal scale to score individuals' ability to perform a certain task.
Total score is 226.
It has excellent inter and intrarater reliability
|
20th week
|
|
Modified Ashworth Scale
Time Frame: 20th week
|
MAS is a tool to measure hypertonia.
It scores the resistance on a 5 point ordinal scale with an increase value indicating hypertonia.
Intrarater reliability of MAS was found to be good to excellent for upper (k= 0.71-0.94)
and lower extremities(k= 0.55-0.97)
while interrater reliability was poor to moderate for upper (k= 0.25-0.66)
and lower extremities
|
20th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroke Specific Quality of Life questionnaire
Time Frame: 20th week
|
It is used for estimating the quality of life of stroke patients.
It contains 49 questions related to different personal and social aspects.
Scoring is done on a ordinal scale of 1-5 with an increase score indicating independence.
It is a valid and reliable tool to use in stroke population
|
20th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University
Publications and helpful links
General Publications
- Chow AD, Shin J, Wang H, Kellawan JM, Pereira HM. Influence of Transcranial Direct Current Stimulation Dosage and Associated Therapy on Motor Recovery Post-stroke: A Systematic Review and Meta-Analysis. Front Aging Neurosci. 2022 Mar 18;14:821915. doi: 10.3389/fnagi.2022.821915. eCollection 2022.
- Wang H, Yu H, Liu M, Xu G, Guo L, Wang C, Sun C. Effects of tDCS on brain functional network of patients after stroke. IEEE Access. 2020 Nov 13;8:205625-34
- Wang H, Chandrashekhar R, Rippetoe J, Ghazi M. Focal muscle vibration for stroke rehabilitation: a review of vibration parameters and protocols. Applied Sciences. 2020 Nov 21;10(22):8270
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Muscle Spasticity
- Stroke
- Motor Activity
- Therapeutics
- Behavioral Disciplines and Activities
- Rehabilitation
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
- Physical Therapy Modalities
Other Study ID Numbers
- Maliha REC02168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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