Clinical trial NCT01201629: Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm
Official title: Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Infarction
Brain Ischemia
Keywords: Ischemic Strokes
t DC stimulation
Functional recovery
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
First posted: 2010-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

Detailed description: Study design:

Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.

Eligibility criteria:

Inclusion criteria:

1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
2. Ischemic stroke documented clinically and by neuroimaging.
3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
6. Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
7. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination \[MMSE\] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

Exclusion criteria:

1. Hemorrhagic strokes
2. Patient's with an episode post-stroke seizure or history of epilepsy.
3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
5. Stroke patients with implanted pacemakers and defibrillators.
6. Refusal to provide informed consent

Eligibility criteria: Inclusion Criteria:

1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
2. Ischemic stroke documented clinically and by neuroimaging.
3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
6. Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
7. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination \[MMSE\] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

Exclusion Criteria:

1. Hemorrhagic strokes
2. Patient's with an episode post-stroke seizure or history of epilepsy.
3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
5. Stroke patients with implanted pacemakers and defibrillators.
6. Refusal to provide informed consent

Primary outcomes:
measure: Total Functional Independence Measure (TFIM) Change Scores
timeFrame: from baseline to 4-weeks of therapy
Secondary outcomes:
measure: Action Research Arm Test (ARAT) Change Scores
timeFrame: baseline to after 4-weeks of therapy
measure: Discharge Disposition
timeFrame: after 4 weeks of intervention
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Medical Center
state: Oklahoma
Study officials:
affiliation: Oklahoma University
name: Meheroz H Rabadi, MD, MRCPI
role: PRINCIPAL_INVESTIGATOR
References: