NCT02039206CompletedPhase 2
The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Brainsway
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Scale for the Assessment and Rating of Ataxia (SARA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Treatment
Experimental
Deep TMS
Intervention: Deep TMS (Device)
Outcomes
Primary Outcomes
Scale for the Assessment and Rating of Ataxia (SARA)
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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