Spinocerebellar Atrophy (SCA)NCT01983670
The Investigation of the Pre-movement Facilitation of Agonist-antagonist Muscles and the Effect of the Feedforward Rehabilitation in Individuals With Hypermetria
A study testing Temporal electrical stimulation in people with Spinocerebellar Atrophy (SCA), run by Chang Gung University at 1 site in Taiwan.
Trial summary
In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed movement. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Atrophy (SCA)
- What is being tested?
- Temporal electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Jun 2012
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed movement. Based on the previous studies, ballistic goal-directed movements are controlled by a triphasic pattern of agonistic and antagonistic muscle activation. The origin of the EMG pattern is a central program, whereas the delayed onset of antagonistic muscle firing has been reported to be the cause of hypermetria. To develop a therapy method, the difference in temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts between healthy adults and individuals with SCA when performing rapid and slow goal-directed movements should be further investigated.
Traditional rehabilitations of individuals with cerebellum lesion were limited to improve the functional performance of movement. Since the deficits of the goal-directed movement are at pre-movement programming, only feedforward training will be possible to re-establish an appropriate program.
Read more
Previous showed that peripheral stimulation resulted in a facilitation of motor cortex. Our group also found that this facilitation in individuals with SCA was similar to the ones without SCA. Therefore, it is possible to adjust the control pattern of supraspinal excitability of agonist and antagonist busts of SCA patient with passively providing electrical stimulation contains normal control pattern of healthy human.
The present study sought to investigate the difference in temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts between healthy adults and individuals with SCA when performing rapid and slow goal-directed movements.
- Conditions
- Spinocerebellar Atrophy (SCA)
- Being tested
- Temporal electrical stimulation
- Keywords
- Pre-movement facilitation, Fast goal directed movement, Triphasic EMG pattern, Temporal electrical stimulation,, Spinocerebellar Ataxia
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal electrical stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| health group 1 | Experimental | Health subjects received 30 mins delay antagonist activation temporal ES. Receives: Other: Temporal electrical stimulation |
| SCA group 1 | Experimental | SCA subjects received four weeks temporal ES assisted home training program. Receives: Other: Temporal electrical stimulation |
| health group 2 | No intervention | health subjects controlled group |
| SCA group 2 | No intervention | SCA subjects controlled group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle evoked potential(MEP)
Measure of changes in MEP of flexor carpi radialis.
Measured: Baseline, 4 weeks.
Electromyography(EMG)
Measure of changes in EMG of flexor carpi radialis and extensor carpi radialis.
Measured: Baseline, 4 weeks
Movement error
Measure of changes in movement error during fast 30 degrees wrist extensions.
Measured: Baseline, 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
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 Atrophy (SCA)Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01983670
- Sponsor's protocol ID
- 98-0951B
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang YZ, Chang YS, Hsu MJ, Wong AM, Chang YJ. Restoration of Central Programmed Movement Pattern by Temporal Electrical Stimulation-Assisted Training in Patients with Spinal Cerebellar Atrophy. Neural Plast. 2015;2015:462182. doi: 10.1155/2015/462182. Epub 2015 Aug 31.
PubMed 26417459
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Pre-movement Facilitation of Agonist-antagonist Muscles and the Effect of the Feedforward Rehabilitation in Individuals With Hypermetria
- ClinicalTrials.gov ID
- NCT01983670
- Acronym / sponsor ID
- 98-0951B
- Conditions
- Spinocerebellar Atrophy (SCA)
- Keywords
- Pre-movement facilitation, Fast goal directed movement, Triphasic EMG pattern, Temporal electrical stimulation,, Spinocerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Nov 2013 (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.
In individuals with spino-cerebellar atrophy (SCA), the delayed onset of antagonist muscle firing has been reported to be the cause of hypermetria. Hypermetria is a common deficit in individuals with spino-cerebellar atrophy SCA when they perform ballistic goal-directed movement. Based on the previous studies, ballistic goal-directed movements are controlled by a triphasic pattern of agonistic and antagonistic muscle activation. The origin of the EMG pattern is a central program, whereas the delayed onset of antagonistic muscle firing has been reported to be the cause of hypermetria. To develop a therapy method, the difference in temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts between healthy adults and individuals with SCA when performing rapid and slow goal-directed movements should be further investigated.
Traditional rehabilitations of individuals with cerebellum lesion were limited to improve the functional performance of movement. Since the deficits of the goal-directed movement are at pre-movement programming, only feedforward training will be possible to re-establish an appropriate program.
Previous showed that peripheral stimulation resulted in a facilitation of motor cortex. Our group also found that this facilitation in individuals with SCA was similar to the ones without SCA. Therefore, it is possible to adjust the control pattern of supraspinal excitability of agonist and antagonist busts of SCA patient with passively providing electrical stimulation contains normal control pattern of healthy human.
The present study sought to investigate the difference in temporal pattern and intensity of supraspinal excitability of agonist and antagonist bursts between healthy adults and individuals with SCA when performing rapid and slow goal-directed movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| health group 1 | Experimental | Other: Temporal electrical stimulationHealth subjects received 30 mins delay antagonist activation temporal ES. |
| SCA group 1 | Experimental | Other: Temporal electrical stimulationSCA subjects received four weeks temporal ES assisted home training program. |
| health group 2 | No intervention | –health subjects controlled group |
| SCA group 2 | No intervention | –SCA subjects controlled group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of spinocerebellar ataxia
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 |
|---|---|---|
| Temporal electrical stimulation | Other | SCA group 1, health group 1 |
Primary outcome
Muscle evoked potential(MEP)
Time frame: Baseline, 4 weeks.
Measure of changes in MEP of flexor carpi radialis.
Electromyography(EMG)
Time frame: Baseline, 4 weeks
Measure of changes in EMG of flexor carpi radialis and extensor carpi radialis.
Movement error
Time frame: Baseline, 4weeks
Measure of changes in movement error during fast 30 degrees wrist extensions.
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 14 Nov 2013.
- Derived from this study: PubMed 26417459Huang YZ, Chang YS, Hsu MJ, Wong AM, Chang YJ. Restoration of Central Programmed Movement Pattern by Temporal Electrical Stimulation-Assisted Training in Patients with Spinal Cerebellar Atrophy. Neural Plast. 2015;2015:462182. doi: 10.1155/2015/462182. Epub 2015 Aug 31.
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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 Temporal electrical stimulation in people with Spinocerebellar Atrophy (SCA), 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 1 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 14 Nov 2013. 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?
Muscle evoked potential(MEP) (time frame: Baseline, 4 weeks.). The study lists 3 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 NCT01983670, 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 14 Nov 2013.