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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01983670
Other study ID # 98-0951B
Secondary ID
Status Completed
Phase N/A
First received November 7, 2013
Last updated November 7, 2013
Start date July 2009
Est. completion date June 2012

Study information

Verified date November 2013
Source Chang Gung University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of spinocerebellar ataxia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Temporal electrical stimulation


Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle evoked potential(MEP) Measure of changes in MEP of flexor carpi radialis. Baseline, 4 weeks. No
Primary Electromyography(EMG) Measure of changes in EMG of flexor carpi radialis and extensor carpi radialis. Baseline, 4 weeks No
Primary Movement error Measure of changes in movement error during fast 30 degrees wrist extensions. Baseline, 4weeks No