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Deep Brain Stimulation for patients with Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Side-Effects

Deep Brain Stimulation for patients with Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Side-Effects - Deep Brain Stimulation for Tardive Dyskinesia and or Dystonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41413
Enrollment
32
Registered
2015-03-10
Start date
2015-10-06
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

movement disorder secondary dystonia

Interventions

All patients will be treated with DBS in the posteroventrolateral GPi.

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Primary objective, improvement on the movement disorder rating scales.

Secondary

MeasureTime frame
Secondary objectives improvement on the quality of life measured on the SF36 and the WHO-QoL including a cost effectiveness analysis, psychiatric stability as measured on the BPRS and the MADRS and cognitive effects as measured with the test battery used in the Nstaps trial.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)