Deep Brain Stimulation for patients with Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Side-Effects
- Conditions
- movement disordersecondary dystonia1002803710037176
- Registration Number
- NL-OMON41413
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
- Mental competence
- Age between 18 and 65 years
- A current or previous psychiatric illness that has been stable for at least 6 months
- Diagnosis of TDD
- TDD must be present for at least 12 months and impede physical and or social functioning
- BFMDRS >8 or AIMS >16
- Pharmacological treatments for TDD had insufficient effect or could not be tolerated
- The patient does not fully comprehend the effects and potential side effects of brain surgery
- The patient is suicidal
- The patient has cognitive impairments
- The patient is severely mentally ill
- A neurological disease that explains the dyskinesia or dystonia
- Use of recreational drugs within the last 3 months
- Previous DBS or ablative stereotactic brain surgery
- General contraindications for stereotactic surgery and general anaesthesia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective, improvement on the movement disorder rating scales.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives improvement on the quality of life measured on the SF36<br /><br>and the WHO-QoL including a cost effectiveness analysis, psychiatric stability<br /><br>as measured on the BPRS and the MADRS and cognitive effects as measured with<br /><br>the test battery used in the Nstaps trial.</p><br>