Status:
UNKNOWN
Effects of Deep Brain Stimulation of the Dentate Nucleus on Cerebellar Ataxia
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Cerebellar Ataxia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 transcrania...
Detailed Description
Ten patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. The initial focus is vascular and ...
Eligibility Criteria
Inclusion
- Patients with diagnosis of chronic cerebellar ataxia (\> 6 months);
- Age ≥18 years;
- Be able to understand study protocol;
- Signed, written informed consent (approved by the Institutional Ethics Committee) obtained prior to any study procedure;
- Refractory symptoms response to first, second and third line pharmacological treatment;
- Daily living activities impaired because the ataxia;
- Be able to undergo surgery procedures.
Exclusion
- Abuse of alcohol, drugs
- Known psychiatric conditions
- Contraindications to DBS
- Heart failure or cardiac disease that contraindicates surgery procedures;
- Pacemaker or other stimulators implanted active;
- Positive blood ß-HCG test for women;
- Other medical conditions demand hospitalization; Participation in other clinical studies at the same time;
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03341416
Start Date
September 1 2017
End Date
January 1 2019
Last Update
November 17 2017
Active Locations (1)
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1
Rubens Cury
São Paulo, São Paulo, Brazil