Trans Cranial Brain Stimulation for Stroke Rehabilitation

NCT03122821 | Completed DMC

• 1 other identifier: MajmaahU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Noninvasive brain stimulation (NIBS) refers to a group of modalities that are used to induce electric currents to and within the brain for diagnostic or therapeutic purposes. Two major types of NIBS techniques are currently in use on humans for clinical and research applications: Transcranial Magnetic Stimulation (TMS) and Transcranial Current Stimulation (tCS). Moreover, the studies evaluating the clinical benefit of mental practice in stroke so far are mostly small feasibility studies, while the few randomized controlled trials reported had relatively small sample sizes. As such, the evidence for mental practice in the treatment of movement disorders following stroke, and other neurological conditions, remains somewhat anecdotal. Purpose of our research is to show the effect of combining brain stimulation and mental imagery on functional recovery of upper limb in stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl Meyers scale for upper limb

  Subjects will be rated on impairment of upper limb. The maximum score of 66 for the upper limb, higher scores imply better outcomes.

  15 minutes

Secondary Outcomes (1)

• Action research Arm Test

  15 minutes

Study Arms (2)

Group 1

EXPERIMENTAL

Real Trans-cranial direct stimulation + Mental Imagery

Other: Real Transcranial direct stimulation+Mental Imagery

Group 2

ACTIVE COMPARATOR

Sham Trans-cranial direct stimulation + Mental imagery

Other: Sham Transcranial Direct Stimulation +Mental Imagery

Interventions

Real Transcranial direct stimulation+Mental Imagery OTHER

The subject will be practicing mental imagery along with mental imagery. A video of the task will be played in front of the patient and the subject will be asked to perform the mental practice of the activity.The video will be played thrice.The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or "Transcranial Micropolarization"), is the most commonly used type of tCS \[2, 19-25\]. It employs a battery-driven stimulator to deliver weak direct currents (1.5 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 2 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 2 weeks

Group 1

Sham Transcranial Direct Stimulation +Mental Imagery OTHER

The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or "Transcranial Micropolarization"), is the most commonly used type of tCS \[2, 19-25\]. It employs a battery-driven stimulator to deliver weak direct currents (1.5 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 2 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 2 weeks

Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Having stroke past 6 months.

You may not qualify if:

• Subarachnoid hemorrhage
• Prior to stroke resulting in aphasia
• Brain surgery in the past
• Epileptic activity in the past 12 months
• Premorbid (suspected) dementia
• Premorbid psychiatric disease affecting communication (for example, personality disorder)
• Excessive use of alcohol or drugs
• Presence of a cardiac pacemaker
• Metal implants

Sponsors & Collaborators

• Majmaah University: lead

Study Sites (1)

NIIMS University hospital

Jaipur, Rajasthan, 303121, India

Location

Related Publications (31)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Faizan Z Kashoo, Masters

  Majmaah University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: transcranial electrical stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Transcranial magnetic stimulation

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 21, 2017
• Study Start: April 12, 2017
• Primary Completion: August 15, 2022
• Study Completion: September 1, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)