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

• Sponsor: Chang Gung University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02103075
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 3
• Duration (Months): 38
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinocerebellar Ataxia	Device: Neuromuscular electrical stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Oct 1, 2005
• Actual Study Completion Date: Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The SCA	Device: Neuromuscular electrical stimulation; All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.
Experimental: The age-matched control	Device: Neuromuscular electrical stimulation; All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.
Experimental: The young control	Device: Neuromuscular electrical stimulation; All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.

Outcome Measures

Primary Outcome Measures

1. Central Motor Excitability [Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.]

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

2. Peripheral Motor Excitability [Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung University	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ya-Ju Chang, Professor, Chang Gung University
• ClinicalTrials.gov Identifier: NCT02103075
• Other Study ID Numbers: 91-221
• First Posted: Apr 3, 2014
• Last Update Posted: Apr 3, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Ya-Ju Chang, Professor, Chang Gung University: spinocerebellar ataxia (SCA); motor evoked potential (MEP); Neuromuscular electrical stimulation (NMES); silent period; cerebellum
• Additional relevant MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations

Study Results

No Results Posted as of Apr 3, 2014