Brief Summary

Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Despite the development of many interventions for movement recovery post-stroke, rehabilitation treatments are minimally effective to the muscle synergy impairment. Previous studies have found that muscle synergy impairment is associated with the damage to the corticospinal tract and the maladaptive recruitment of the contralesional cortico-reticulospinal tract. The investigators hypothesize that facilitating the damaged cortico-spinal tract (via primary motor cortex) and/or inhibiting the contralesional cortico-reticulospinal tract (via dorsal premotor cortex) will reduce muscle synergy impairment. In this pilot project, the investigators propose to run a proof-of-concept pilot trial to evaluate the effect of the targeted high-definition transcranial direct current stimulation (HD-tDCS) on mitigating muscle synergy impairment.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable stroke

Timeline

Completed

Started Jan 2022

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

November 9, 2021

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed

15 days until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 29, 2024

Completed

Last Updated

July 29, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

November 9, 2021

Results QC Date

May 25, 2023

Last Update Submit

February 12, 2024

Conditions

Stroke

Keywords

Strokeupper limb impairmentHD-tDCS

Outcome Measures

Primary Outcomes (1)

Fugl-Meyer Upper Extremity Assessment Part A
The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66.
The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .

Secondary Outcomes (1)

Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP)
The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).

Other Outcomes (1)

Change in Brain Symmetry Index
The BSI assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).