The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-30

Brief Summary

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To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population.

Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.

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Detailed Description

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Conditions

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Machado Joseph Disease (SCA3)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Deep TMS

Group Type EXPERIMENTAL

Deep TMS

Intervention Type DEVICE

1Hz Stimulation

Interventions

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Deep TMS

1Hz Stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.

Exclusion Criteria

1. Patients who have concomitant epilepsy.
2. History of seizure or heat convulsion.
3. Patients on neuroleptics.
4. Patients with dementia (MMSE\<25) or any unstable medical disorder.
5. History or current unstable hypertension.
6. History of head injury or neurosurgical interventions.
7. History of any metal in the head (outside the mouth).
8. Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
9. History of frequent or severe headaches.
10. History of migraine.
11. History of hearing loss.
12. History of cochlear implants
13. History of drug abuse or alcoholism.
14. Pregnancy or not using a reliable method of birth control.
15. Participation in current clinical study or clinical study within 30 days prior to this study.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No