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Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis

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ClinicalTrials.gov Identifier: NCT04574973
Recruitment Status : Terminated (Relocation of PI)
First Posted : October 5, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky

Brief Summary:
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: transcranial direct current stimulation Behavioral: intensive upper extremity motor training Not Applicable

Detailed Description:
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : January 8, 2021
Actual Study Completion Date : January 8, 2021

Arm Intervention/treatment
Experimental: Anodal tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.

Experimental: Cathodal tDCS
Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.

Experimental: Dual tDCS
Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.

Sham Comparator: Sham tDCS
Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity.
Device: transcranial direct current stimulation
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

Behavioral: intensive upper extremity motor training
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.




Primary Outcome Measures :
  1. Change in Fugl-Meyer Assessment from baseline [ Time Frame: Baseline, Immediately post-intervention, one-month follow-up ]
    This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.


Secondary Outcome Measures :
  1. Change in Action Research Arm Test from baseline [ Time Frame: Baseline, Immediately post-intervention, one-month follow-up ]
    This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.

  2. Change in Stroke Impact Scale from baseline [ Time Frame: Baseline, Immediately post-intervention, one-month follow-up ]
    This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement.

  3. Change in cortical motor map from baseline [ Time Frame: Baseline, Immediately post-intervention, one-month follow-up ]
    This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 or more months post-stroke
  • Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees

Exclusion Criteria:

  • Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
  • Untreated depression
  • History of multiple strokes

Exclusion criteria for TMS evaluations:

  • History of head injury with loss of consciousness
  • History of severe alcohol or drug abuse, or psychiatric illness
  • Positive pregnancy test or being of childbearing age and not using appropriate contraception
  • Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
  • Cardiac or neural pacemakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574973


Locations
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United States, Kentucky
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
University of Kentucky
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Responsible Party: Lumy Sawaki, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04574973    
Other Study ID Numbers: 47644
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lumy Sawaki, University of Kentucky:
neuroplasticity
rehabilitation
transcranial direct current stimulation
motor training
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations