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

Not Applicable

Terminated

• Conditions: Brain Infarction; Brain Ischemia
• Interventions: Device: t DC stimulation; Device: tDCStimulation

• Registration Number: NCT01201629
• Lead Sponsor: University of Oklahoma

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

Study Timeline

• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Study Start: 2010-09-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Results First Submitted: 2017-03-29
• Results First Submitted QC: 2017-03-29
• Last Update Submitted: 2017-03-29
• Results First Posted: 2017-05-10
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
t DC stimulation	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
t DC stimulation	tDCStimulation	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
tDC stimulation	t DC stimulation	Actual DC stimulation
tDC stimulation	tDCStimulation	Actual DC stimulation

Primary Outcome Measures

Name	Time	Method
Total Functional Independence Measure (TFIM) Change Scores	from baseline to 4-weeks of therapy	The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT) Change Scores	baseline to after 4-weeks of therapy	The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal
Discharge Disposition	after 4 weeks of intervention	Patient discharged home or to sub-acute facility

Trial Locations

Locations (1)

Oklahoma City VA Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States