Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ela B Plow, PhD, PT, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01539096
First received: February 16, 2012
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Procedure: tDCS: noninvasive brain stimulation
Behavioral: Constraint induced movement therapy (CIMT)
Procedure: Sham tDCS: placebo noninvasive brain stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change in Upper limb function following combination of tDCS with CIMT [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Study of change in neural mechanisms that underlie the complementary association of cortical stimulation and CIMT [ Time Frame: 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) ] [ Designated as safety issue: No ]
    To identify the underlying neural mechanisms in the association of cortical stimulation and CIMT, the patient will undergo structural and functional magnetic resonance imaging (MRI) and tests of neurophysiology.


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham tDCS plus CIMT
Subjects in this group will be trained on constraint-induced movement therapy for the hand while concurrently receiving placebo noninvasive brain stimulation (tDCS). 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)
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.
Other Names:
  • hand therapy
  • CIMT
  • forced use therapy
  • constraint induced movement therapy
  • stroke therapy
  • stroke rehabilitation
Procedure: Sham tDCS: placebo noninvasive brain stimulation
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.
Experimental: tDCS plus CIMT
Patients with stroke affecting the hand will receive constraint-induced movement therapy (CIMT) concurrent with noninvasive brain stimulation, called tDCS. 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
TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) 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.
Other Names:
  • tDCS
  • TDCS
  • noninvasive brain stimulation
  • neuromodulation
  • transcranial stimulation
  • TCS
Behavioral: Constraint induced movement therapy (CIMT)
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.
Other Names:
  • hand therapy
  • CIMT
  • forced use therapy
  • constraint induced movement therapy
  • stroke therapy
  • stroke rehabilitation

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539096

Contacts
Contact: Ela B Plow, PhD PT 216-445-4589 plowe2@ccf.org
Contact: Corin Bonnett 216-445-6728 bonnetc2@ccf.org

Locations
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Myranda Long    216-445-6728    longm3@ccf.org   
Contact: Corin Bonnett, BS    216-445-6728    bonnetc2@ccf.org   
Principal Investigator: Ela B Plow, PhD PT         
Sub-Investigator: Andre Machado, MD PhD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Ela B Plow, PhD PT The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ela B Plow, PhD, PT, Principal Investigator, Staff, Neural Control Lab, Dept. of Biomedical Engineering, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01539096     History of Changes
Other Study ID Numbers: 11-586, 1K01HD069504-01
Study First Received: February 16, 2012
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Rehabilitation
Stroke
Paresis
Paralysis
Recovery
tDCS
Transcranial Direct Current Stimulation
CIMT
Constraint Induced Movement Therapy
Stroke therapy
MRI
Hand
CVA
Cerebrovascular accident

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014