Tardive Dyskinesia Clinical Trial
Official title:
Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Effects
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
n/a
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