Focal Muscle Vibration and tDCS on Motor Recovery in Stroke

NCT ID: NCT06893653

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-01-31

Brief Summary

Although tDCS and FV have shown some benefit as stand-alone treatment, researcher suggest that combining intervention with complementary mechanism can lead to additive or synergistic benefits which might yield more significant improvement in functional outcome hence the author propose to plan the combination of FV with tDCS for motor recovery /spasticity in stroke patients.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

FMV

FMV + PT

Group Type: ACTIVE_COMPARATOR

Focal muscle vibration

Intervention Type: DEVICE

FMV will be applied to the muscle belly along with the conventional physical therapy

Physical Therapy

Intervention Type: OTHER

Conventional physical therapy will be provided

tDCS

tDCS + PT

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

tDCS will be applied to M1 area of brain along with the conventional physical therapy

Physical Therapy

Intervention Type: OTHER

Conventional physical therapy will be provided

FMV & tDCS

FMV + tDCS + PT

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Conventional physical therapy will be provided

Focal muscle vibration & tDCS

Intervention Type: DEVICE

Focal muscle vibration with tDCS and conventional physical therapy will be provided.

PT

PT only

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Conventional physical therapy will be provided

Interventions

Focal muscle vibration

FMV will be applied to the muscle belly along with the conventional physical therapy

Intervention Type: DEVICE

tDCS

tDCS will be applied to M1 area of brain along with the conventional physical therapy

Intervention Type: DEVICE

Physical Therapy

Conventional physical therapy will be provided

Intervention Type: OTHER

Focal muscle vibration & tDCS

Focal muscle vibration with tDCS and conventional physical therapy will be provided.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Maliha Sayyad, DPT

Role: CONTACT

malihasayyad9@gmail.com

0092 341 2734811

Mirza Obaid Baig, MSPT

Role: CONTACT

obaid.baig@riphah.edu.pk

00923332238706

Facility Contacts

Maliha Sayyad, DPT

Role: primary

malihasayyad9@gmail.com

0092 341 2734811

Mirza Obaid Baig, MSPT

Role: backup

obaid.baig@riphah.edu.pk

0092 333 2238706

References

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.

Reference Type: BACKGROUND

PMID: 35370603 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

MalihaREC02168

Identifier Type: -

Identifier Source: org_study_id