Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis

Not Applicable

Completed

• Conditions: Stroke; Cerebrovascular Accident
• Interventions: Device: Neuroconn Eldith stimulator by Magstim

• Registration Number: NCT03124147
• Lead Sponsor: Lumy Sawaki

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.)

Detailed Description

This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization.

To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training.

Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-21
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 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°.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anodal tDCS with motor training	Neuroconn Eldith stimulator by Magstim	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.
Dual tDCS with motor training	Neuroconn Eldith stimulator by Magstim	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.
Sham tDCS with motor training	Neuroconn Eldith stimulator by Magstim	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.
Cathodal tDCS with motor training	Neuroconn Eldith stimulator by Magstim	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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