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Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery (TDCS+OT)

Primary Purpose

Stroke, Cerebrovascular Accident, CVA

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation, Recovery, Neurorehabilitation, Plasticity

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • First time clinical ischemic stroke or cerebrovascular accident
  • At least 5 months out from first ischemic stroke prior to study enrollment

Exclusion Criteria:

  • More than 1 stroke (older strokes)
  • Significant pre-stroke disability
  • A terminal medical illness or disorder with survival of less than 1 year
  • Co-existent major neurological or psychiatric diseases (e.g., epilepsy)
  • Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents
  • Active participation in other stroke recovery trials testing interventions

Sites / Locations

  • Beth Israel Deaconess Medical Center / Harvard Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real-tDCS + PT-OT

Sham-tDCS + PT-OT

Arm Description

Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.

Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment of Upper Extremity Motor Impairment
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.

Secondary Outcome Measures

Wolf-Motor-Function-Test
The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.

Full Information

First Posted
November 17, 2008
Last Updated
May 2, 2018
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00792428
Brief Title
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
Acronym
TDCS+OT
Official Title
Facilitating Motor Recovery After Stroke Using tDCS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 1, 2013 (Actual)
Study Completion Date
February 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, CVA, Acute Stroke, Acute Cerebrovascular Accident, Apoplexy
Keywords
Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation, Recovery, Neurorehabilitation, Plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real-tDCS + PT-OT
Arm Type
Active Comparator
Arm Description
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Arm Title
Sham-tDCS + PT-OT
Arm Type
Sham Comparator
Arm Description
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Intervention Type
Device
Intervention Name(s)
Real Transcranial Direct Current Stimulation
Other Intervention Name(s)
Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
Intervention Description
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Other Intervention Name(s)
Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
Intervention Description
A sham current runs between two electrode positions and might affect the underlying brain tissue.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
Description
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Time Frame
Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Secondary Outcome Measure Information:
Title
Wolf-Motor-Function-Test
Description
The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.
Time Frame
Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First time clinical ischemic stroke or cerebrovascular accident At least 5 months out from first ischemic stroke prior to study enrollment Exclusion Criteria: More than 1 stroke (older strokes) Significant pre-stroke disability A terminal medical illness or disorder with survival of less than 1 year Co-existent major neurological or psychiatric diseases (e.g., epilepsy) Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents Active participation in other stroke recovery trials testing interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gottfried Schlaug, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center / Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center / Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18973584
Citation
Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73. doi: 10.1111/j.1460-9568.2008.06459.x.
Results Reference
background
PubMed Identifier
18957075
Citation
Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103.
Results Reference
background
PubMed Identifier
17070707
Citation
Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. doi: 10.1016/j.neuroimage.2006.09.010. Epub 2006 Oct 27.
Results Reference
background
PubMed Identifier
16603933
Citation
Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4. doi: 10.1097/00001756-200604240-00023.
Results Reference
background
PubMed Identifier
21068427
Citation
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
Results Reference
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Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

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