NCT02524886

Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Effects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GGZ Centraal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Tardive dyskinesia and dystonia (TDD) are severe side effects of dopamine blocking agents, particularly antipsychotics. Deep brain stimulation (DBS) has shown to be effective in the treatment of TDD in psychiatric patients, but only reported in case reports and small clinical trials and with little attention to possible psychiatric or cognitive complications or positive effect on psychiatric symptoms. Objective: To assess whether treatment with DBS can reduce or resolve TDD and if DBS can induce beneficial or side-effects in particular psychiatric symptoms. Study design: A delayed onset double blind randomised controlled trial. Study population: Adult patients with a current or previous psychiatric disorder and antipsychotic induced TDD with a stable psychiatric status during the past 6 months. Intervention: All patients will be treated with DBS in the posteroventrolateral GPi. The groups will be randomised into immediate stimulation or delayed stimulation after 3 months. Main study parameters/endpoints: Primary objective, improvement on the movement rating scales BFMDRS. Secondary objectives improvement on the quality of life measured on the SF-36, psychiatric stability as measured on the BPRS and the MADRS and cognitive effects as measured on the MATTIS Dementia Rating Scale, Nederlandse Leestest voor Volwassenen (NLV), 15 word test, Facial Expression of Emotion S+T (FEEST), Groninger Intelligentie Test woordopnoemen (GIT), category and letter fluency test, Trail Making Test part A and B and the Stroop colour and word test

Conditions

• Tardive Dyskinesia
• Tardive Dystonia

Interventions

Type	Name	Description
DEVICE	GPi DBS with Medtronic electorde and Activa PC pulsegenerator	The electric stimulation of 2 leads implanted in the Globus Pallidus internus

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-05-02
• Completion: 2017-06-25
• First posted: 2015-08-17
• Last updated: 2017-05-23

Locations

1 site across 1 country: Netherlands