Clinical trial NCT00792428: Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
Official title: Facilitating Motor Recovery After Stroke Using tDCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity Motor Impairment
timeFrame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Secondary outcomes:
measure: Wolf-Motor-Function-Test
timeFrame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center / Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center / Harvard Medical School
name: Gottfried Schlaug, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.