Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

NCT01539096 | Completed Phase 1 DMC

• 2 other identifiers: 11-5861K01HD069504-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether benefits of training the affected hand in patients with stroke can be improved by combining training with a painless, noninvasive technique called Transcranial Direct Current Stimulation (TDCS). TDCS will be applied over the part of the brain responsible for movements of the affected hand. Also, the investigators will study the changes in the brain that favor recovery of hand function following combination of training and tDCS.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Paresis; Paralysis; Recovery; tDCS; Transcranial Direct Current Stimulation; CIMT; Constraint Induced Movement Therapy; Stroke therapy; MRI; Hand; CVA; Cerebrovascular accident

Outcome Measures

Primary Outcomes (1)

• Change in Upper limb function following combination of tDCS with CIMT

  To address the functional advantage of combining tDCS and CIMT tests that evaluate impairments of the hand will be utilized. Also, change in ability to carry out activities of daily living will be measured.

  Each patient will be given the assessment tests at 3 points during the study, at baseline, interim test (an average of 2.5 weeks from baseline) and at posttest (an average of 5 weeks from baseline).

Secondary Outcomes (1)

• Study of change in neural mechanisms that underlie the complementary association of cortical stimulation and CIMT

  Each patient will be given the assessment tests at 3 points during the study, at baseline, interim test (an average of 2.5 weeks from baseline) and at posttest (an average of 5 weeks from baseline)

Study Arms (2)

Sham tDCS plus CIMT

SHAM COMPARATOR

Subjects in this group will be trained on Constraint induced movement therapy (CIMT) for the hand while concurrently receiving placebo noninvasive brain stimulation (tDCS). They will be receiving Sham tDCS: placebo noninvasive brain stimulation. They will be provided treatment for 3 days a week for 5 weeks for 1 hr each day at the Cleveland Clinic. They would be asked to use affected hand in daily activities for 5 hrs everyday at home while wearing a mitt on their unaffected hand.

Behavioral: Constraint induced movement therapy (CIMT); Procedure: Sham tDCS: placebo noninvasive brain stimulation

tDCS plus CIMT

EXPERIMENTAL

Patients with stroke affecting the hand will receive Constraint-induced movement therapy (CIMT) concurrent with tDCS: noninvasive brain stimulation. TDCS will be applied to areas of the brain responsible for movement of the affected hand. This combination of tDCS and CIMT will be delivered for 1 hr each day for 3 days a week for 5 weeks. Patients will also be asked to use their affected hand in daily activities at home for 5 hrs a day while wearing a mitt on the unaffected hand.

Procedure: tDCS: noninvasive brain stimulation; Behavioral: Constraint induced movement therapy (CIMT)

Interventions

tDCS: noninvasive brain stimulation PROCEDURE

TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered for 1 hr each day for 3 days a week for 5 weeks in conjunction with constraint-induced movement therapy for the affected hand.

Also known as: tDCS, noninvasive brain stimulation, neuromodulation, transcranial stimulation, TCS

tDCS plus CIMT

Constraint induced movement therapy (CIMT) BEHAVIORAL

Patients with stroke affecting the hand will receive constraint-induced movement therapy (CIMT) to re-train movements of the affected hand. Training will involve practicing tasks of daily living with qualified personnel. Training will be delivered for 1 hr each day for 3 days a week for 5 weeks. Patients will also be asked to use their affected hand in daily activities at home for 5 hrs a day while wearing a mitt on the unaffected hand.

Also known as: hand therapy, CIMT, forced use therapy, constraint induced movement therapy, stroke therapy, stroke rehabilitation

Sham tDCS plus CIMT; tDCS plus CIMT

Sham tDCS: placebo noninvasive brain stimulation PROCEDURE

Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.

Sham tDCS plus CIMT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with stroke that occurred at least 6 months ago

You may not qualify if:

• Pregnant
• Ongoing use of Central Nervous System activating medications
• Presence of an electrically, magnetically or mechanically activated implant, including cardiac pacemaker, cochlear implant
• Metal in the head
• A history of medication-resistant epilepsy in the family
• Past history of seizures or unexplained spells of loss of consciousness

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• Unger RH, Lowe MJ, Beall EB, Bethoux F, Jones SE, Machado AG, Plow EB, Cunningham DA. Stimulation of the Premotor Cortex Enhances Interhemispheric Functional Connectivity in Association with Upper Limb Motor Recovery in Moderate-to-Severe Chronic Stroke. Brain Connect. 2023 Oct;13(8):453-463. doi: 10.1089/brain.2022.0064. Epub 2023 Apr 10.

  PMID: 36772802 DERIVED

• Plow EB, Cunningham DA, Beall E, Jones S, Wyant A, Bonnett C, Yue GH, Lowe M, Wang XF, Sakaie K, Machado A. Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial. Trials. 2013 Oct 12;14:331. doi: 10.1186/1745-6215-14-331.

  PMID: 24119615 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Paralysis

Interventions

Transcranial Direct Current Stimulation; Transcutaneous Electric Nerve Stimulation; Constraint Induced Movement Therapy; Stroke Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Neurological Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ela B Plow, PhD PT

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff, Neural Control Lab, Dept. of Biomedical Engineering

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 27, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)