Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 2 weeks (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 < 20/30;

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Sham tDCS + mCIMT
Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
  • Device: Sham
    sham group receives no active current stimulation except 15 seconds of current ramp up in the beginning and 15 seconds of current ramp up in the end of the 30-minute session to create a scalp perception to blind the subject.
  • Behavioral: mCIMT
    All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
Active Comparator
2 mA tDCS + mCIMT
2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
  • Device: Low dose tDCS
    The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
  • Behavioral: mCIMT
    All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
Active Comparator
4 mA + mCIMT
4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
  • Device: High dose tDCS
    The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
  • Behavioral: mCIMT
    All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session

Recruiting Locations

University of Alabama
Birmingham, Alabama 35249
Contact:
Tammy Davis, RN
205-975-8572
trdavis@uabmc.edu

More Details

Status
Recruiting
Sponsor
Duke University

Study Contact

Kristina Balderson
(919) 684-0071
Kristina.Balderson@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.