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

Machado Joseph Disease (SCA3) Clinical Trial

Official title:

The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039206
• Other study ID #: MJD MEIR dTMS
• Secondary ID: 0059-13-MMC
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2013
• Last updated: January 24, 2018
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Machado Joseph Disease (SCA3)
• Machado-Joseph Disease

Intervention

Device:
• Deep TMS
1Hz Stimulation

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale for the Assessment and Rating of Ataxia (SARA)		30 days