Back to resultsThe Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
Primary Purpose
Machado Joseph Disease (SCA3)
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Deep TMS
Sponsored by
About this trial
This is an interventional treatment trial for Machado Joseph Disease (SCA3) focused on measuring Machado Joseph disease, Deep TMS, TMS, Transcranial Magnetic Stimulation, SCA3, Magnetic Stimulation, Brainsway
Eligibility Criteria
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.
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Deep TMS
Outcomes
Primary Outcome Measures
Scale for the Assessment and Rating of Ataxia (SARA)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02039206
Brief Title
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brainsway
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Machado Joseph Disease (SCA3)
Keywords
Machado Joseph disease, Deep TMS, TMS, Transcranial Magnetic Stimulation, SCA3, Magnetic Stimulation, Brainsway
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Deep TMS
Intervention Type
Device
Intervention Name(s)
Deep TMS
Intervention Description
1Hz Stimulation
Primary Outcome Measure Information:
Title
Scale for the Assessment and Rating of Ataxia (SARA)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gordon, Prof.
Organizational Affiliation
Meir Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
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