Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
TDCS+OT
Facilitating Motor Recovery After Stroke Using tDCS
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jun 2006
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
July 11, 2017
CompletedJune 4, 2018
May 1, 2018
6.7 years
November 17, 2008
April 14, 2017
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Secondary Outcomes (1)
Wolf-Motor-Function-Test
Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Study Arms (2)
Real-tDCS + PT-OT
ACTIVE COMPARATOREach 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.
Sham-tDCS + PT-OT
SHAM COMPARATOREach 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.
Interventions
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
A sham current runs between two electrode positions and might affect the underlying brain tissue.
Eligibility Criteria
You may qualify if:
- First time clinical ischemic stroke or cerebrovascular accident
- At least 5 months out from first ischemic stroke prior to study enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, 02215, United States
Related Publications (5)
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.
PMID: 18973584BACKGROUNDVines 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.
PMID: 18957075BACKGROUNDNair 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.
PMID: 17070707BACKGROUNDVines 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.
PMID: 16603933BACKGROUNDLindenberg 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.
PMID: 21068427RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gottfried Schlaug, MD, PhD
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gottfried Schlaug, MD, PhD
Beth Israel Deaconess Medical Center / Harvard Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology; Staff Neurologist
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 18, 2008
Study Start
June 1, 2006
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 4, 2018
Results First Posted
July 11, 2017
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share