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

NCT ID: NCT01201629

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-16
• Study Completion Date: 2015-12-31

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

Conditions

Brain Infarction; Brain Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

t DC stimulation

Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects

Group Type: SHAM_COMPARATOR

t DC stimulation

Intervention Type: DEVICE

tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.

tDCStimulation

Intervention Type: DEVICE

1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.

tDC stimulation

Actual DC stimulation

Group Type: EXPERIMENTAL

t DC stimulation

Intervention Type: DEVICE

tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.

tDCStimulation

Intervention Type: DEVICE

1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.

Interventions

t DC stimulation

tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.

Intervention Type: DEVICE

tDCStimulation

1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.

Intervention Type: DEVICE

Other Intervention Names

Sham transcranial DC brain stimulator; Experimental tDC stimulator

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meheroz H Rabadi, MD, MRCPI

Role: PRINCIPAL_INVESTIGATOR

Oklahoma University

Locations

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

1620

Identifier Type: -

Identifier Source: org_study_id