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

Phase 2

Completed

• Conditions: Machado Joseph Disease (SCA3)
• Interventions: Device: Deep TMS

• Registration Number: NCT02039206
• Lead Sponsor: Brainsway

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-29
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2016-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Deep TMS	Deep TMS

Primary Outcome Measures

Name	Time	Method
Scale for the Assessment and Rating of Ataxia (SARA)	30 days

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel