Spinocerebellar AtaxiaNCT02103075
Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia
A study testing Neuromuscular electrical stimulation in people with Spinocerebellar Ataxia, run by Chang Gung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2002to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinocerebellar Ataxia
- Being tested
- Neuromuscular electrical stimulation
- Keywords
- spinocerebellar ataxia (SCA), motor evoked potential (MEP), Neuromuscular electrical stimulation (NMES), silent period, cerebellum
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationDevice
All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.
| Study group | Role | What they receive |
|---|---|---|
| The SCA | Experimental | Not described Receives: Device: Neuromuscular electrical stimulation |
| The age-matched control | Experimental | Not described Receives: Device: Neuromuscular electrical stimulation |
| The young control | Experimental | Not described Receives: Device: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Motor Excitability
Measure of changes in Central Motor Excitability by motor evoked potential and silent period that are measured by transcranial magnetic stimulation.
Measured: 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
Measured: Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startAug 2002
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinocerebellar AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103075
- Sponsor's protocol ID
- 91-221
- Status last verified
- Mar 2014
- First submitted
- 31 Mar 2014
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25434572
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation on Median Nerve Facilitates Low Motor Cortex Excitability in Human With Spinocerebellar Ataxia
- ClinicalTrials.gov ID
- NCT02103075
- Acronym / sponsor ID
- 91-221
- Conditions
- Spinocerebellar Ataxia
- Keywords
- spinocerebellar ataxia (SCA), motor evoked potential (MEP), Neuromuscular electrical stimulation (NMES), silent period, cerebellum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The SCA | Experimental | Device: Neuromuscular electrical stimulation |
| The age-matched control | Experimental | Device: Neuromuscular electrical stimulation |
| The young control | Experimental | Device: Neuromuscular electrical stimulation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationAll groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve. | Device | The SCA, The age-matched control, The young control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Derived from this study: PubMed 25434572Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Spinocerebellar Ataxia, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Motor Excitability (time frame: Baseline, in experiment, 0 minute, 10 minutes, and 20 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.