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

Sponsor

University of Kentucky (Other)

Overall Status

Terminated

CT.gov ID

NCT04574973

Collaborator

(none)

Enrollment

Location

Arms

25.4

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Nov 28, 2018

Actual Primary Completion Date :

Jan 8, 2021

Actual Study Completion Date :

Jan 8, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in Fugl-Meyer Assessment from baseline [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

Change in Action Research Arm Test from baseline [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.
Change in Stroke Impact Scale from baseline [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.
Change in cortical motor map from baseline [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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