The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02039206 |
Recruitment Status
:
Completed
First Posted
: January 17, 2014
Last Update Posted
: January 25, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Deep TMS
|
Device: Deep TMS
1Hz Stimulation
|
- Scale for the Assessment and Rating of Ataxia (SARA) [ Time Frame: 30 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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:
- Patients who have concomitant epilepsy.
- History of seizure or heat convulsion.
- Patients on neuroleptics.
- Patients with dementia (MMSE<25) or any unstable medical disorder.
- History or current unstable hypertension.
- History of head injury or neurosurgical interventions.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of frequent or severe headaches.
- History of migraine.
- History of hearing loss.
- History of cochlear implants
- History of drug abuse or alcoholism.
- Pregnancy or not using a reliable method of birth control.
- Participation in current clinical study or clinical study within 30 days prior to this study.

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
Israel | |
Meir Medical Center | |
Kfar Saba, Israel |
Principal Investigator: | Carlos Gordon, Prof. | Meir Health Center |
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 |