Clinical trial NCT03826030: Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
Official title: TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke, Ischemic
Motor Activity
Upper Extremity Paralysis
Keywords: stroke
stroke recovery
brain stimulation
transcranial direct current stimulation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2019-02-01
Enrollment: 129
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: This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.


Eligibility criteria: Each subject must meet all of the following criteria to participate in this study:

1. 18-80 years old; and
2. First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and
3. \>10° of active wrist extension, \>10° of thumb abduction/extension, and \> 10° of extension in at least 2 additional digits; and
4. Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and
5. An absolute difference of FM-UE scores between the two baseline assessments that is ≤ 2 points indicating stable motor impairment; if subject is not stable, then he/she will be invited for a reassessment after 7-14 days (but no more than 3 reassessments); and
6. Pre-stroke mRS ≤2; and
7. Signed informed consent by the subject or Legally Authorized Representative (LAR).

Each Subject who meets any of the following criteria will be excluded from the study:

1. Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes;
2. Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;
3. Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function;
4. Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study;
5. Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score \< 18/30;
6. History of medically uncontrolled depression or other neuro-psychiatric disorders despite medications either before or after stroke that may affect subject's ability to participate in the study;
7. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later);
8. Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; 8b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone defect or hemicraniectomy;
9. Planning to move from the local area within the next 6 months;
10. Life expectancy less than 6 months;
11. Has received Botulinum toxin injection to the affected upper extremity in the past 3 months prior to randomization or expectation that Botulinum will be given to the Upper Extremity prior to the completion of the last follow-up visit;
12. Concurrent enrollment in another investigational stroke recovery study;
13. Doesn't speak sufficient English to comply with study procedures;
14. Expectation that subject cannot comply with study procedures and visits.

Primary outcomes:
measure: Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale
timeFrame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
Secondary outcomes:
measure: Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)
timeFrame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
measure: Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale
timeFrame: Baseline through day 15 (after the intervention) and follow-up at day 45 and 105
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory Rehabilitation Hospital
state: Georgia
city: Lexington
country: United States
facility: Cardinal Hill Rehabilitation Hospital
state: Kentucky
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: White Plains
country: United States
facility: Burke Rehabilitation Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland VA Medical Center
state: Ohio
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina University Hospital
state: South Carolina
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
Study officials:
affiliation: Duke University
name: Wayne Feng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baystate Health
name: Gottfried Schlaug, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: