Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, 02215, United States
NCT Number: NCT00792428
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.
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Notify Me21 year–80 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Other names: Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
A sham current runs between two electrode positions and might affect the underlying brain tissue.
Other names: Non-invasive brain stimulation, Brain stimulation, Enhancing stroke recovery
Time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
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
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.
Beth Israel Deaconess Medical Center
Other
Facilitating Motor Recovery After Stroke Using tDCS
Acronym: TDCS+OT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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