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

NCT04574973 | Terminated

• 1 other identifier: 47644
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

neuroplasticity; rehabilitation; transcranial direct current stimulation; motor training

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment from baseline

  This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.

  Baseline, Immediately post-intervention, one-month follow-up

Secondary Outcomes (3)

• Change in Action Research Arm Test from baseline

  Baseline, Immediately post-intervention, one-month follow-up

• Change in Stroke Impact Scale from baseline

  Baseline, Immediately post-intervention, one-month follow-up

• Change in cortical motor map from baseline

  Baseline, Immediately post-intervention, one-month follow-up

Study Arms (4)

Anodal tDCS

EXPERIMENTAL

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; Behavioral: intensive upper extremity motor training

Cathodal tDCS

EXPERIMENTAL

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; Behavioral: intensive upper extremity motor training

Dual tDCS

EXPERIMENTAL

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; Behavioral: intensive upper extremity motor training

Sham tDCS

SHAM COMPARATOR

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; Behavioral: intensive upper extremity motor training

Interventions

transcranial direct current stimulation DEVICE

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

Anodal tDCS; Cathodal tDCS; Dual tDCS; Sham tDCS

intensive upper extremity motor training 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.

Anodal tDCS; Cathodal tDCS; Dual tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: November 28, 2018
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

US (1)