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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

December 29, 2013
January 17, 2014
January 25, 2018
February 2014
February 2015   (Final data collection date for primary outcome measure)
Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT02039206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Machado Joseph Disease (SCA3)
Device: Deep TMS
1Hz Stimulation
Experimental: Treatment
Deep TMS
Intervention: Device: Deep TMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
June 2016
February 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT02039206
MJD MEIR dTMS
0059-13-MMC ( Other Identifier: BRAINSWAY )
Yes
Not Provided
Not Provided
Brainsway
Brainsway
Not Provided
Principal Investigator: Carlos Gordon, Prof. Meir Health Center
Brainsway
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP