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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04574973
Status
Terminated
Sponsor
University of Kentucky

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.