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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Brainsway.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Brainsway Identifier:
First received: December 29, 2013
Last updated: September 15, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Machado Joseph Disease (SCA3) Device: Deep TMS Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Brainsway:

Primary Outcome Measures:
  • Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 30 days ]

Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Deep TMS
Device: Deep TMS
1Hz Stimulation


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02039206

Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Carlos Gordon, Prof.    00-972-9-7471581   
Principal Investigator: Carlos Gordon, Prof.         
Sponsors and Collaborators
Principal Investigator: Carlos Gordon, Prof. Meir Health Center
  More Information

Responsible Party: Brainsway Identifier: NCT02039206     History of Changes
Other Study ID Numbers: MJD MEIR dTMS
0059-13-MMC ( Other Identifier: BRAINSWAY )
Study First Received: December 29, 2013
Last Updated: September 15, 2014

Keywords provided by Brainsway:
Machado Joseph disease
Deep TMS
Transcranial Magnetic Stimulation
Magnetic Stimulation

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Cerebellar Ataxia
Machado-Joseph Disease
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinocerebellar Degenerations
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Neurologic Manifestations
Genetic Diseases, Inborn processed this record on September 21, 2017