Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

Stroke Clinical Trial

— TDCS+OT  

Official title:

Facilitating Motor Recovery After Stroke Using tDCS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792428
• Other study ID #: 2005P000346
• Secondary ID: R01NS045049
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: February 1, 2013

Study information

• Verified date: May 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2013
• Est. primary completion date: February 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cerebrovascular Accident
• Acute Stroke
• Apoplexy
• Cerebrovascular Accident
• CVA
• Stroke

Intervention

Device:
• Real Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
• Sham Transcranial Direct Current Stimulation
A sham current runs between two electrode positions and might affect the underlying brain tissue.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center / Harvard Medical School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Epub 2006 Oct 27. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days