Electrical Stimulation Combined With Motor Training on EE... | NCT03277534

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

NCT03277534

Sponsor

National Yang Ming Chiao Tung University

Status

Completed

Last Update Posted

Sep 11, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Electrical stimulation
Sham electrical stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2013Actual

Primary Completion Date

Jan 4, 2017Actual

Completion Date

Jan 4, 2017Actual

First Submitted Date

Sep 5, 2017

First Submission Date that Met QC Criteria

Sep 6, 2017

First Posted Date

Sep 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2017

Last Update Posted Date

Sep 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Li-Wei Chou, Associate professor, National Yang Ming Chiao Tung UniversityPrincipal Investigator

Lead Sponsor

National Yang Ming Chiao Tung UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electrical stimulation	Experimental		Other: Electrical stimulation
Control	Sham Comparator		Other: Sham electrical stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrical stimulation	Other	sensory electrical stimulation was applied prior to upper limb functional training	Electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment for Upper Extremity	evaluate changes in upper extremity function of the stroke subjects	before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
EEG-EMG coherence	evaluate changes in functional connectivity between motor cortex and active muscles	before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004558	Electric Stimulation

Ancestor Terms

ID	Term
D010812	Physical Stimulation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided