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

NCT01201629 | Terminated Results

• 1 other identifier: 1620
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Infarction; Brain Ischemia

Keywords

Ischemic Strokes; t DC stimulation; Functional recovery

Outcome Measures

Primary Outcomes (1)

• Total Functional Independence Measure (TFIM) Change Scores

  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.

  from baseline to 4-weeks of therapy

Secondary Outcomes (2)

• Action Research Arm Test (ARAT) Change Scores

  baseline to after 4-weeks of therapy

• Discharge Disposition

  after 4 weeks of intervention

Study Arms (2)

t DC stimulation

SHAM COMPARATOR

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; Device: tDCStimulation

tDC stimulation

EXPERIMENTAL

Actual DC stimulation

Device: t DC stimulation; Device: tDCStimulation

Interventions

t DC stimulation 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.

Also known as: Sham transcranial DC brain stimulator

t DC stimulation; tDC stimulation

tDCStimulation 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.

Also known as: Experimental tDC stimulator

t DC stimulation; tDC stimulation

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
• Ischemic stroke documented clinically and by neuroimaging.
• Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
• Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
• Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Brain Infarction; Brain Ischemia; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr. Meheroz H. Rabadi
• Organization: OKC VA Medical Center

meheroz.rabadi@va.gov

405-456-5298

Study Officials

• Meheroz H Rabadi, MD, MRCPI

  Oklahoma University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 14, 2010
• Study Start: September 16, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Locations

US (1)