Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

Sponsors

Lead sponsor: The Cleveland Clinic

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Source The Cleveland Clinic
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.

Detailed Description

The overall goal of this study is to develop a novel rehabilitative method, in chronic stroke, which minimizes residual deficits by maximally utilizing the potential for cortical plasticity.

Despite extensive rehabilitation, approximately 60-80% of patients with stroke experience residual dysfunction of the upper limb. Deficits are believed to linger due to neurophysiologic imbalance between the ipsilesional (stroke-affected) and contralesional (intact) motor cortices. Specifically, the ipsilesional motor cortex loses its normal inhibitory control over the contralesional areas, which, in return, intensify their inhibitory influence upon the former. Constraint-Induced Movement Therapy (CIMT) represents a family of techniques that alleviates residual deficits by rectifying these neurophysiologic imbalances. By reinforcing use of the paretic upper limb in daily life during restraint of the non-paretic limb, CIMT initiates use-dependent neuroplastic reorganization implicating the ipsilesional motor areas, which demonstrate return-of-activity and regain territory in the surviving regions, mitigating the exaggerated inhibitory influence exerted by the contralesional areas.

Despite promising evidence, however, clinical utility of CIMT is limited due to its labor-intensive protocols and inadequate gains. Our objective is to address gaps in existing clinical rehabilitative research. The investigators propose to 1) combine CIMT with targeted stimulation of the ipsilesional motor cortices, 2) Use a novel, noninvasive method of stimulation, called transcranial direct current stimulation (tDCS), 3) Use multimodal imaging to determine comprehensive mechanisms of recovery in patients. Our central hypotheses are 1) ipsilesional motor cortices would be an ideal site for delivering stimulation during CIMT, 2) tDCS will be easy, safe and inexpensive to apply and will target multiple maps concurrently during rehabilitation as demonstrated in our elemental research. 3) structural and functional imaging methods will demonstrate complementary cortical, corticospinal and cortico-muscular markers of recovery.

Overall Status Active, not recruiting
Start Date July 2011
Completion Date December 2019
Primary Completion Date December 2019
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Upper limb function following combination of tDCS with 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).
Secondary Outcome
Measure Time Frame
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)
Enrollment 30
Condition
Intervention

Intervention type: Procedure

Intervention name: tDCS: noninvasive brain stimulation

Description: 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.

Arm group label: tDCS plus CIMT

Intervention type: Behavioral

Intervention name: Constraint induced movement therapy (CIMT)

Description: 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.

Intervention type: Procedure

Intervention name: Sham tDCS: placebo noninvasive brain stimulation

Description: 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.

Arm group label: Sham tDCS plus CIMT

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosed with stroke that occurred at least 6 months ago

Exclusion Criteria:

- 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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ela B Plow, PhD PT Principal Investigator The Cleveland Clinic
Location
facility The Cleveland Clinic
Location Countries

United States

Verification Date

March 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: The Cleveland Clinic

Investigator full name: Ela B Plow, PhD, PT

Investigator title: Principal Investigator, Staff, Neural Control Lab, Dept. of Biomedical Engineering

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Sham tDCS plus CIMT

Arm group type: Sham Comparator

Description: 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.

Arm group label: tDCS plus CIMT

Arm group type: Experimental

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov