Clinical trial NCT04574973: Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Official title: Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: neuroplasticity
rehabilitation
transcranial direct current stimulation
motor training
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Fugl-Meyer Assessment from baseline
timeFrame: Baseline, Immediately post-intervention, one-month follow-up
Secondary outcomes:
measure: Change in Action Research Arm Test from baseline
timeFrame: Baseline, Immediately post-intervention, one-month follow-up
measure: Change in Stroke Impact Scale from baseline
timeFrame: Baseline, Immediately post-intervention, one-month follow-up
measure: Change in cortical motor map from baseline
timeFrame: Baseline, Immediately post-intervention, one-month follow-up
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky at Cardinal Hill Rehabilitation Hospital
state: Kentucky
Study officials:
References: