Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

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Brief Title

Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

Official Title

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

Brief 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
    



Study Type

Interventional


Primary Outcome

DBS efficacy as measured as the change on the Burke Fahn Marsden Dystonia Rating Scale (BFMDRS)

Secondary Outcome

 Psychiatric safety as measured on the Brief Psychiatric Rating Scale (BPRS) and the Montgomery-Åsberg Depression Rating Scale (MADRS)

Condition

Tardive Dyskinesia

Intervention

GPi DBS with Medtronic electorde and Activa PC pulsegenerator

Study Arms / Comparison Groups

 Immediate stimulation
Description:  Patients will be implanted with a Medtronic electorde and Active PC pulse generator for deep brain stimulation at baseline and GPi electric stimulation will start immediately after surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1

Start Date

June 2015

Completion Date

June 25, 2017

Primary Completion Date

May 2, 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Mental competence*

          -  A current or previous psychiatric illness that has been stable for at least the last
             six months, meaning no overt psychiatric symptoms or decompensation based on a written
             report of the clinician that is treating the patient

          -  Diagnosis of TDD, TDD symptoms developed whilst being treated with dopamine blocking
             agents or within three months (for oral) or within six months (for depot) after
             withdrawal (definition international review of neurobiology 98)(6)

          -  TDD must be present for at least 12 months and impede with physical and or social
             functioning. In this study that is defined as a score of at least 4 on the disability
             rating scale of the BFMDRS with at least two items scoring a minimum of two, or one
             item scoring a 3 or higher.

          -  BFMDRS >12 at the moment of evaluation

          -  The patient has proven treatment refractory for all other evidence based TDD
             treatments:

               -  Withdrawal of the dopamine blocking agents or a switch to clozapine and/or
                  quetiapine for at least 3 months

               -  Adding tetrabenazine at the maximum tolerated dosage for at least 4 weeks

               -  In focal dystonia a trial with Botulinum toxin (at least three sessions)

          -  The patient fully understands that DBS is not a treatment for the psychiatric disorder
             and agrees to take his or her psychiatric medication as prescribed by their
             psychiatrist.

        Exclusion Criteria:

          -  The patient has unrealistic expectations of the possible benefit of DBS or does not
             fully understand the possible side effects and the likelihood of their occurring.

          -  The patient is suicidal, a score of ≥4 on item 19 on the BPRS

          -  Mattis scale for dementia <120

          -  A score of ≥6 on the Clinical Global Impression scale (CGI) psychiatric severity scale
             or a BPRS ≥68

          -  A neurological disease that is the cause of the dyskinesia and/or dystonia

          -  Use of recreational drugs, such cocaine amphetamine or other drugs that affect TDD,
             within the last 3 months. Cannabis use within the last 3 months is not considered an
             exclusion criteria

          -  Previous DBS or ablative stereotactic brain surgery

          -  General contraindications for stereotactic surgery and general anaesthesia (e.g.
             severe hypertension, blood coagulation disorder)

          -  A seizure disorder that is not sufficiently controlled

          -  An implanted electronic device

          -  A language barrier that prevents the patients from understanding the investigators or
             vice versa
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Peter N van Harted, MD, PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT02524886

Organization ID

DBS for TD


Responsible Party

Sponsor

Study Sponsor

GGZ Centraal

Collaborators

 University Medical Center Groningen

Study Sponsor

Peter N van Harted, MD, PhD, Principal Investigator, GGZ Centraal


Verification Date

May 2017