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

NCT ID: NCT04574973

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2021-01-08

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.

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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 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.

Group Type: SHAM_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.

intensive upper extremity motor training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kentucky

OTHER

Sponsor Role: lead

Responsible Party

Lumy Sawaki

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

47644

Identifier Type: -

Identifier Source: org_study_id