Transcranial Direct Current Stimulation (tDCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of Oklahoma
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01201629
First received: September 7, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Brain Infarction
Brain Ischemia
Device: t DC stimulation
Device: tDCStimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Transcranial Direct Current Stimulation (tDCS) Improve Functional Motor Recovery in the Affected Arm-hand in Patients After an Acute Ischemic Stroke?Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • total Functional Independence Measure (TFIM) [ Time Frame: after 4-weeks of therapy ] [ Designated as safety issue: No ]
    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:
  • Action Research Arm Test (ARAT) [ Time Frame: after 4-weeks of therapy ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201629

Contacts
Contact: Meheroz H Rabadi, MD, MRCPI 405-456-5298 rabadimh@gmail.com

Locations
United States, Oklahoma
Oklahoma City VA Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Meheroz H Rabadi, MD, MRCPI         
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Meheroz H Rabadi, MD, MRCPI Oklahoma University
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01201629     History of Changes
Other Study ID Numbers: 14128
Study First Received: September 7, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Ischemic Strokes
t DC stimulation
Functional recovery

Additional relevant MeSH terms:
Brain Ischemia
Infarction
Ischemia
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Stroke

ClinicalTrials.gov processed this record on July 31, 2014