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

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ClinicalTrials.gov Identifier: NCT02039206
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

Study Description
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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.


Condition or disease Intervention/treatment Phase
Machado Joseph Disease (SCA3) Device: Deep TMS Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : June 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Deep TMS
 Device: Deep TMS
1Hz Stimulation


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

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

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039206


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Brainsway
Investigators
Principal Investigator: Carlos Gordon, Prof. Meir Health Center
More Information
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Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT02039206     History of Changes
Other Study ID Numbers: MJD MEIR dTMS
0059-13-MMC ( Other Identifier: BRAINSWAY )
First Posted: January 17, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Brainsway:
Machado Joseph disease
Deep TMS
TMS
Transcranial Magnetic Stimulation
 SCA3
Magnetic Stimulation
Brainsway

Additional relevant MeSH terms:
Spinocerebellar Ataxias
Cerebellar Ataxia
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
Dyskinesias
Neurologic Manifestations
Genetic Diseases, Inborn