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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Electrical stimulation

Sham electrical stimulation

About this trial

This is an interventional other trial for Stroke focused on measuring electrical stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electrical stimulation

Control

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment for Upper Extremity

evaluate changes in upper extremity function of the stroke subjects

EEG-EMG coherence

evaluate changes in functional connectivity between motor cortex and active muscles

Secondary Outcome Measures

Full Information

NCT ID

NCT03277534

First Posted

September 5, 2017

Last Updated

September 6, 2017

Sponsor

National Yang Ming University

1. Study Identification

Unique Protocol Identification Number

NCT03277534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

August 28, 2013 (Actual)

Primary Completion Date

January 4, 2017 (Actual)

Study Completion Date

January 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

electrical stimulation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electrical stimulation

Arm Type

Experimental

Arm Title

Control

Arm Type

Sham Comparator

Intervention Type

Other

Intervention Name(s)

Electrical stimulation

Intervention Description

sensory electrical stimulation was applied prior to upper limb functional training

Intervention Type

Other

Intervention Name(s)

Sham electrical stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment for Upper Extremity

Description

evaluate changes in upper extremity function of the stroke subjects

Time Frame

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

Title

EEG-EMG coherence

Description

evaluate changes in functional connectivity between motor cortex and active muscles

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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