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Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

Primary Purpose

Tardive Dyskinesia, Tardive Dystonia

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

GPi DBS with Medtronic electorde and Activa PC pulsegenerator

About this trial

This is an interventional treatment trial for Tardive Dyskinesia focused on measuring Deep Brain Simulation, Psychiatric, Side-effects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zon en Schild

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Immediate stimulation

Delayed stimulation

Arm 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

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

Outcomes

Primary Outcome Measures

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

The Efficacy of the DBS as measured on the Burke Fahn Marsden Dystonia Rating Scale (BFMDRS)

Secondary Outcome Measures

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

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)

Cognitive side effects as measured using neuropsychological test battery

Cognitive effects of DBS as measured using neuropsychological test battery

Quality of life as measured on the Short Form 36 (SF-36) and the World Health Organiasation Brief Quality of Life Score (WHO-Bref)

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)

Full Information

NCT ID

NCT02524886

First Posted

July 27, 2015

Last Updated

May 22, 2017

Sponsor

GGZ Centraal

Collaborators

University Medical Center Groningen, Maastricht University

1. Study Identification

Unique Protocol Identification Number

NCT02524886

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

It was not possible to recruit and include a sufficient number of patients within the timeframe.

Study Start Date

June 2015 (Actual)

Primary Completion Date

May 2, 2017 (Actual)

Study Completion Date

June 25, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GGZ Centraal

Collaborators

University Medical Center Groningen, Maastricht University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tardive Dyskinesia, Tardive Dystonia

Keywords

Deep Brain Simulation, Psychiatric, Side-effects

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immediate stimulation

Arm Type

Active Comparator

Arm 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

Arm Title

Delayed stimulation

Arm Type

Sham Comparator

Arm 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 3 months after surgery

Intervention Type

Device

Intervention Name(s)

GPi DBS with Medtronic electorde and Activa PC pulsegenerator

Other Intervention Name(s)

DBS, GPi-DBS

Intervention Description

The electric stimulation of 2 leads implanted in the Globus Pallidus internus

Primary Outcome Measure Information:

Title

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

Description

The Efficacy of the DBS as measured 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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Cognitive side effects as measured using neuropsychological test battery

Description

Cognitive effects of DBS 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

Title

Quality of life as measured on the Short Form 36 (SF-36) and the World Health Organiasation Brief Quality of Life Score (WHO-Bref)

Description

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)

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter N van Harted, MD, PhD

Organizational Affiliation

GGZ Centraal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zon en Schild

City

Amersfoort

State/Province

Utrecht

ZIP/Postal Code

3818EW

Country

Netherlands

12. IPD Sharing Statement

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Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia

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