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Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

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ClinicalTrials.gov Identifier: NCT02524886
Recruitment Status : Terminated (It was not possible to recruit and include a sufficient number of patients within the timeframe.)
First Posted : August 17, 2015
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
University Medical Center Groningen
Maastricht University
Information provided by (Responsible Party):
GGZ Centraal

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


Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Tardive Dystonia Device: GPi DBS with Medtronic electorde and Activa PC pulsegenerator Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Effects
Actual Study Start Date : June 2015
Actual Primary Completion Date : May 2, 2017
Estimated Study Completion Date : June 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arm Intervention/treatment
Active Comparator: Immediate stimulation
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
Device: GPi DBS with Medtronic electorde and Activa PC pulsegenerator
The electric stimulation of 2 leads implanted in the Globus Pallidus internus
Other Names:
  • DBS
  • GPi-DBS

Sham Comparator: Delayed stimulation
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 3 months after surgery
Device: GPi DBS with Medtronic electorde and Activa PC pulsegenerator
The electric stimulation of 2 leads implanted in the Globus Pallidus internus
Other Names:
  • DBS
  • GPi-DBS




Primary Outcome Measures :
  1. DBS efficacy as measured as the change on the Burke Fahn Marsden Dystonia Rating Scale (BFMDRS) [ Time Frame: Entire study, measurement at 0, 3, 6 and 12 months for immediate stimulation group and 0, 3, 6, 9, 15 months for the delayed stimulation group ]
    The Efficacy of the DBS as measured on the Burke Fahn Marsden Dystonia Rating Scale (BFMDRS)


Secondary Outcome Measures :
  1. Psychiatric safety as measured on the Brief Psychiatric Rating Scale (BPRS) and the Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Entire study, measurement at 0, 1.5, 3, 6 and 12 months for immediate stimulation group and 0, 1.5, 3, 6, 9, 15 months for the delayed stimulation group ]
    Relaps of a pre-exsisting psychiatric condition or the development of a new psychiatric condition as measured on the Brief Psychiatric Rating Scale (BPRS) and the Montgomery-Åsberg Depression Rating Scale (MADRS)

  2. Cognitive side effects as measured using neuropsychological test battery [ Time Frame: Entire study, measurement at 0, 3 and 12 months for immediate stimulation group and 0, 3 and 15 months for the delayed stimulation group ]
    Cognitive effects of DBS as measured using neuropsychological test battery

  3. Quality of life as measured on the Short Form 36 (SF-36) and the World Health Organiasation Brief Quality of Life Score (WHO-Bref) [ Time Frame: Entire study, measurement at 0, 3, 6 and 12 months for immediate stimulation group and 0, 3, 6, 9, 15 months for the delayed stimulation group ]
    The effect of DBS stimulation on the quality of life as measured on the Short Form 36 (SF-36) and the World Health Organiasation Brief Quality of Life Score (WHO-Bref)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524886


Locations
Netherlands
Zon en Schild
Amersfoort, Utrecht, Netherlands, 3818EW
Sponsors and Collaborators
GGZ Centraal
University Medical Center Groningen
Maastricht University
Investigators
Principal Investigator: Peter N van Harted, MD, PhD GGZ Centraal

Responsible Party: GGZ Centraal
ClinicalTrials.gov Identifier: NCT02524886     History of Changes
Other Study ID Numbers: DBS for TD
First Posted: August 17, 2015    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by GGZ Centraal:
Deep Brain Simulation
Psychiatric
Side-effects

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Tardive Dyskinesia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Dyskinesia, Drug-Induced