NCT02103075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
Last Updated

April 3, 2014

Status Verified

March 1, 2014

Enrollment Period

3.2 years

First QC Date

March 31, 2014

Last Update Submit

March 31, 2014

Conditions

Keywords

spinocerebellar ataxia (SCA)motor evoked potential (MEP)Neuromuscular electrical stimulation (NMES)silent periodcerebellum

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (3)

The SCA

EXPERIMENTAL
Device: Neuromuscular electrical stimulation

The age-matched control

EXPERIMENTAL
Device: Neuromuscular electrical stimulation

The young control

EXPERIMENTAL
Device: Neuromuscular electrical stimulation

Interventions

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

The SCAThe age-matched controlThe young control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Spinocerebellar Ataxias

Condition Hierarchy (Ancestors)

Cerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinocerebellar DegenerationsSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesAtaxiaDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

August 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

April 3, 2014

Record last verified: 2014-03

Locations