Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

NCT03124147 | Completed

• 1 other identifier: 11CRP7220009
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the effectiveness of different polarities of transcranial direct current stimulation paired with intensive motor training in recovery of upper extremity function in individuals with severe post-stroke hemiparesis. The hypothesis is that more severely impaired individuals will derive greater benefit from anodal stimulation of the ipsilesional hemisphere or cathodal stimulation of the contralesional hemisphere than dual stimulation (anodal applied to the ipsilesional hemisphere and cathodal applied to the contralesional hemisphere.)

Conditions

Stroke; Cerebrovascular Accident

Keywords

motor recovery; neuroplasticity; chronic; human; noninvasive brain stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in Fugl Meyer Assessment

  Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

Secondary Outcomes (2)

• Change in Action Research Arm Test

  Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

• Change in Stroke Impact Scale

  Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline

Study Arms (4)

Anodal tDCS with motor training

ACTIVE COMPARATOR

20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

Device: Neuroconn Eldith stimulator by Magstim

Cathodal tDCS with motor training

ACTIVE COMPARATOR

20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

Device: Neuroconn Eldith stimulator by Magstim

Dual tDCS with motor training

ACTIVE COMPARATOR

20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

Device: Neuroconn Eldith stimulator by Magstim

Sham tDCS with motor training

SHAM COMPARATOR

20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training. Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.

Device: Neuroconn Eldith stimulator by Magstim

Interventions

Neuroconn Eldith stimulator by Magstim DEVICE

Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.

Anodal tDCS with motor training; Cathodal tDCS with motor training; Dual tDCS with motor training; Sham tDCS with motor training

Eligibility Criteria

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

You may qualify if:

• Chronic stroke patients
• Single stroke
• Chronic (more than 12 months after from stroke)
• At least 18 years old, but there is no upper age range for this project.
• Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

You may not qualify if:

• History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
• Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
• Cognitive deficit severe enough to preclude informed consent
• Positive pregnancy test or being of childbearing age and not using appropriate contraception
• Participants with history of untreated depression.

Sponsors & Collaborators

• Lumy Sawaki: lead

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 21, 2017
• Study Start: August 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share