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Completed

NCT Number: NCT03277534

Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke

This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first-ever cerebral cortical region involved chronic stroke, onset over a month,
  • able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
  • at stable medical condition for intervention

Exclusion criteria

  • history of other neurological disorders,
  • cognitive impairment (Mini-Mental State Examination score <24, MMSE),26
  • unable to follow orders,
  • contraindications of ES, and
  • under 20 years old

Treatment and study plan

Electrical Stimulation

Other

sensory electrical stimulation was applied prior to upper limb functional training

Sham electrical stimulation

Other

electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied

Primary outcomes

  1. Fugl-Meyer Assessment for Upper Extremity

    Time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended

    evaluate changes in upper extremity function of the stroke subjects

  2. EEG-EMG coherence

    Time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended

    evaluate changes in functional connectivity between motor cortex and active muscles

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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