Machado Joseph Disease (SCA3)Phase 2NCT02039206
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease
A Phase 2 study testing Deep TMS in people with Machado Joseph Disease (SCA3), run by Brainsway at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Machado Joseph Disease (SCA3)
- What is being tested?
- Deep TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Machado Joseph Disease (SCA3)
- Being tested
- Deep TMS
- Keywords
- Machado Joseph disease, Deep TMS, TMS, Transcranial Magnetic Stimulation, SCA3, Magnetic Stimulation, Brainsway
- Medical subject headings
- Machado-Joseph Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep TMSDevice
1Hz Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Deep TMS Receives: Device: Deep TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment and Rating of Ataxia (SARA)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Machado Joseph Disease (SCA3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gordon, Prof., Principal investigator, Meir Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039206
- Sponsor's protocol ID
- MJD MEIR dTMS
- Other IDs
- 0059-13-MMC
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02039206
- Acronym / sponsor ID
- MJD MEIR dTMS
- Conditions
- Machado Joseph Disease (SCA3)
- Keywords
- Machado Joseph disease, Deep TMS, TMS, Transcranial Magnetic Stimulation, SCA3, Magnetic Stimulation, Brainsway
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Deep TMSDeep TMS |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep TMS1Hz Stimulation | Device | Treatment |
Primary outcome
Scale for the Assessment and Rating of Ataxia (SARA)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gordon, Prof. principal investigator
Meir Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep TMS in people with Machado Joseph Disease (SCA3), run by Brainsway at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for the Assessment and Rating of Ataxia (SARA) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.