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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04574973
• Other study ID #: 47644
• Status: Terminated
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: January 8, 2021

Study information

• Verified date: January 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Action Research Arm Test from baseline	This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.	Baseline, Immediately post-intervention, one-month follow-up
Secondary	Change in Stroke Impact Scale from baseline	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.	Baseline, Immediately post-intervention, one-month follow-up
Secondary	Change in cortical motor map from baseline	This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.	Baseline, Immediately post-intervention, one-month follow-up