Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

Brain Ischemia Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Infarction
• Brain Ischemia

• NCT number: NCT01201629
• Study type: Interventional
• Source: University of Oklahoma
• Status: Terminated
• Phase: Phase 2
• Start date: January 2009
• Completion date: December 2015