Clinical trial NCT00542256: tDCS and Physical Therapy in Stroke
Official title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Apoplexy
Cerebral Stroke
Cerebrovascular Accident, Acute
Cerebrovascular Apoplexy
Cerebrovascular Stroke
CVA (Cerebrovascular Accident)
Stroke
Stroke, Acute
Vascular Accident, Brain
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-10-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Eligibility criteria: Inclusion Criteria:

* First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
* Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
* Ability to stand from a sitting position and ability to stand with or without upper extremity support
* Stroke onset at least 6 months prior to study enrollment

Exclusion Criteria:

* Significant pre-stroke disability
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* Excessive pain in any joint of the paretic extremity
* A terminal medical diagnosis consistent with survival of less than 1 year
* Advanced liver, kidney, cardiac, or pulmonary disease
* Coexistent major neurological or psychiatric disease (including epilepsy)
* A history of significant alcohol or drug abuse in the prior 3 years
* Use of neuropsychotropic drugs - such as antidepressants
* Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
* Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test
timeFrame: Baseline, Treatment days 1,5,10, Follow Up
measure: Motor Activity Log Rating Scale
timeFrame: Baseline, Treatment Days 1,5,10 and Follow Up
measure: Beck Depression Inventory
timeFrame: Baseline, Treatment days 1,5,10 and Follow up
measure: Visual Analogue Scale for Anxiety
timeFrame: Baseline, Treatment days 1,5,10 and Follow Up
Secondary outcomes:
measure: Fugl Meyer Assessment of Motor Recovery
timeFrame: Baseline Assessment
measure: Barthel Index Score
timeFrame: Baseline Assessment
measure: Modified Ashworth Scale
timeFrame: Baseline Assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Felipe Fregni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.