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Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia

Primary Purpose

Spinocerebellar Ataxia

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Neuromuscular electrical stimulation

About this trial

This is an interventional treatment trial for Spinocerebellar Ataxia focused on measuring spinocerebellar ataxia (SCA), motor evoked potential (MEP), Neuromuscular electrical stimulation (NMES), silent period, cerebellum

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of Spinocerebellar ataxia
No history of epilepsy
No other neuromuscular disorder
No fracture within the last six months and restricted movement on the upper extremity
Limited trembling hand allowed for the EMG recording.

Sites / Locations

Chang Gung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

The SCA

The age-matched control

The young control

Arm Description

Outcomes

Primary Outcome Measures

Central Motor Excitability

Measure of changes in Central Motor Excitability by motor evoked potential and silent period that are measured by transcranial magnetic stimulation.

Peripheral Motor Excitability

Measure of changes in peripheral motor excitability by Maximum M wave and H reflex

Secondary Outcome Measures

Full Information

NCT ID

NCT02103075

First Posted

March 31, 2014

Last Updated

March 31, 2014

Sponsor

Chang Gung University

1. Study Identification

Unique Protocol Identification Number

NCT02103075

Brief Title

Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

October 2005 (Actual)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Spinocerebellar ataxia (SCA) is a hereditary disorder with movement incoordination. The ataxia performed low intra-cortical facilitation mainly due to the degenerative cerebellum. Noninvasive sensory stimulations such as peripheral electrical stimulation were reported to modulate the excitability of the motor excitability. Neuromuscular electrical stimulation (NMES) was proposed as a neuromodulation tool for the aberrant motor excitability on the SCA. This study aims to investigate the effect of NMES on the motor excitability in the SCA, and the differentiation on the central or peripheral motor excitability changed by the NMES.

6. Conditions and Keywords

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

Spinocerebellar Ataxia

Keywords

spinocerebellar ataxia (SCA), motor evoked potential (MEP), Neuromuscular electrical stimulation (NMES), silent period, cerebellum

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The SCA

Arm Type

Experimental

Arm Title

The age-matched control

Arm Type

Experimental

Arm Title

The young control

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Neuromuscular electrical stimulation

Intervention Description

All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.

Primary Outcome Measure Information:

Title

Central Motor Excitability

Description

Measure of changes in Central Motor Excitability by motor evoked potential and silent period that are measured by transcranial magnetic stimulation.

Time Frame

Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.

Title

Peripheral Motor Excitability

Description

Measure of changes in peripheral motor excitability by Maximum M wave and H reflex

Time Frame

Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of Spinocerebellar ataxia No history of epilepsy No other neuromuscular disorder No fracture within the last six months and restricted movement on the upper extremity Limited trembling hand allowed for the EMG recording.

Facility Information:

Facility Name

Chang Gung University

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25434572

Citation

Chen CC, Chuang YF, Yang HC, Hsu MJ, Huang YZ, Chang YJ. Neuromuscular electrical stimulation of the median nerve facilitates low motor cortex excitability in patients with spinocerebellar ataxia. J Electromyogr Kinesiol. 2015 Feb;25(1):143-50. doi: 10.1016/j.jelekin.2014.10.009. Epub 2014 Nov 1.

Results Reference

derived

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Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia

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