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

Spinocerebellar Ataxia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103075
• Other study ID #: 91-221
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: March 31, 2014
• Start date: August 2002
• Est. completion date: October 2005

Study information

• Verified date: March 2014
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ataxia
• Spinocerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Motor Excitability	Measure of changes in Central Motor Excitability by motor evoked potential and silent period that are measured by transcranial magnetic stimulation.	Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.	Yes
Primary	Peripheral Motor Excitability	Measure of changes in peripheral motor excitability by Maximum M wave and H reflex	Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.	Yes