Cerebellar Ataxia Clinical Trial
Official title:
Deep Brain Stimulation on Cerebellar Ataxia
Verified date | November 2017 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. The hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients and in these patients, chronic cerebellar stimulation through deep brain stimulation could be a therapeutic option. The rationale is to stimulate the dentate nucleus of the cerebellum in order to balance the functional asymmetry observed between both motor cortices after chronic cerebellar lesions.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | January 1, 2019 |
Est. primary completion date | July 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients with diagnosis of chronic cerebellar ataxia (> 6 months); 2. Age =18 years; 3. Be able to understand study protocol; 4. Signed, written informed consent (approved by the Institutional Ethics Committee) obtained prior to any study procedure; 5. Refractory symptoms response to first, second and third line pharmacological treatment; 6. Daily living activities impaired because the ataxia; 7. Be able to undergo surgery procedures. Exclusion Criteria: 1. Abuse of alcohol, drugs 2. Known psychiatric conditions 3. Contraindications to DBS 4. Heart failure or cardiac disease that contraindicates surgery procedures; 5. Pacemaker or other stimulators implanted active; 6. Positive blood ß-HCG test for women; 7. Other medical conditions demand hospitalization; Participation in other clinical studies at the same time; |
Country | Name | City | State |
---|---|---|---|
Brazil | Rubens Cury | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary outcome - change in Scale for the assessment and rating of ataxia - SARA | To evaluate prospectively the effect of DN-DBS in ataxia. The primary outcome is the change between the Scale for the assessment and rating of ataxia (SARA, ranging from 0-40, higher scores mean more severe ataxia) at baseline and after surgery during the active DBS-ON phase | change in the SARA score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on. | |
Secondary | Secondary outcome - change in tremor score using the Fahn Tolosa Marin Scale | To evaluate prospectively the effect of DN-DBS on tremor. The secondary outcome is the change between the Fahn Tolosa Marin Scale (ranging from 0-40, higher scores mean worse tremor) at baseline and after surgery during the active DBS-ON phase | change in the Fahn Tolosa Marin Scale score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on. | |
Secondary | Secondary outcome - quality of life | To evaluate prospectively the effect of DN-DBS on quality of life. The secondary outcome is the change between the World Health Organization Quality of Life (WHOQOL-bref, 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment, higher scores mean better quality of life) at baseline and after surgery during the active DBS-ON phase | change in the WHOQOL-bref score between the baseline versus after surgery during ON-stimulation deep brain stimulation phase. This phase lasts 1 month, so the evaluation will be performed 01 months after the stimulation is turned on. |
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