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

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ClinicalTrials.gov Identifier: NCT02103075
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Ya-Ju Chang, Chang Gung University

Tracking Information
First Submitted Date  ICMJE March 31, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date April 3, 2014
Study Start Date  ICMJE August 2002
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Central Motor Excitability [ Time Frame: 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.
  • Peripheral Motor Excitability [ Time Frame: Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes. ]
    Measure of changes in peripheral motor excitability by Maximum M wave and H reflex
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Spinocerebellar Ataxia
Intervention  ICMJE Device: Neuromuscular electrical stimulation
All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.
Study Arms  ICMJE
  • Experimental: The SCA
    Intervention: Device: Neuromuscular electrical stimulation
  • Experimental: The age-matched control
    Intervention: Device: Neuromuscular electrical stimulation
  • Experimental: The young control
    Intervention: Device: Neuromuscular electrical stimulation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02103075
Other Study ID Numbers  ICMJE 91-221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ya-Ju Chang, Chang Gung University
Study Sponsor  ICMJE Chang Gung University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP