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

Brainsway

Status and phase: Completed; Phase 2

Conditions: Machado Joseph Disease (SCA3)

Treatments: Device: Deep TMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02039206

MJD MEIR dTMS

0059-13-MMC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

Deep TMS

Treatment:

Device: Deep TMS