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

• ClinicalTrials.gov Identifier: NCT01201629
• Recruitment Status: Terminated
• First Posted: September 14, 2010
• Results First Posted: May 10, 2017
• Last Update Posted: May 10, 2017
• Sponsor: University of Oklahoma
• Collaborator: VA Office of Research and Development
• Information provided by (Responsible Party): University of Oklahoma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Brain Infarction; Brain Ischemia	Device: t DC stimulation; Device: tDCStimulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 16, 2010
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: 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	Device: 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.; Other Name: Sham transcranial DC brain stimulator; 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.; Other Name: Experimental tDC stimulator
Experimental: tDC stimulation; Actual DC stimulation	Device: 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.; Other Name: Sham transcranial DC brain stimulator; 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.; Other Name: Experimental tDC stimulator

Outcome Measures

Primary Outcome Measures :

1. Total Functional Independence Measure (TFIM) Change Scores [ Time Frame: 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 :

1. Action Research Arm Test (ARAT) Change Scores [ Time Frame: 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
2. Discharge Disposition [ Time Frame: after 4 weeks of intervention ]
   Patient discharged home or to sub-acute facility

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oklahoma

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

VA Office of Research and Development

Investigators

• Principal Investigator: Meheroz H Rabadi, MD, MRCPI; Oklahoma University

More Information

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01201629
• Other Study ID Numbers: 1620
• First Posted: September 14, 2010
• Results First Posted: May 10, 2017
• Last Update Posted: May 10, 2017
• Last Verified: March 2017

Keywords provided by University of Oklahoma:

Ischemic Strokes; t DC stimulation; Functional recovery

Additional relevant MeSH terms:

Brain Ischemia; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases