Tardive DyskinesiaNCT02524886
Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia
A study testing GPi DBS with Medtronic electorde and Activa PC pulsegenerator in people with Tardive Dyskinesia and Tardive Dystonia, run by GGZ Centraal at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tardive Dyskinesia, Tardive Dystonia
- What is being tested?
- GPi DBS with Medtronic electorde and Activa PC pulsegenerator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to 25 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- GPi DBS with Medtronic electorde and Activa PC pulsegenerator
- Keywords
- Deep Brain Simulation, Psychiatric, Side-effects
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPi DBS with Medtronic electorde and Activa PC pulsegeneratorDevice
Also called DBS, GPi-DBS
The electric stimulation of 2 leads implanted in the Globus Pallidus internus
| Study group | Role | What they receive |
|---|---|---|
| Immediate stimulation | Active comparator | 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 Receives: Device: GPi DBS with Medtronic electorde and Activa PC pulsegenerator |
| Delayed stimulation | Sham comparator | 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 Receives: Device: GPi DBS with Medtronic electorde and Activa PC pulsegenerator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (3)
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)
Measured: 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
Cognitive side effects as measured using neuropsychological test battery
Cognitive effects of DBS as measured using neuropsychological test battery
Measured: Entire study, measurement at 0, 3 and 12 months for immediate stimulation group and 0, 3 and 15 months for the delayed stimulation group
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startJun 2015
- Primary completion2 May 2017
- Study completion25 Jun 2017 (estimated)
Why it stopped: It was not possible to recruit and include a sufficient number of patients within the timeframe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GGZ Centraal
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Peter N van Harted, MD, PhD, Principal investigator, GGZ Centraal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524886
- Sponsor's protocol ID
- DBS for TD
- Status last verified
- May 2017
- First submitted
- 27 Jul 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia. Efficacy and Psychiatric and Cognitive Effects
- ClinicalTrials.gov ID
- NCT02524886
- Acronym / sponsor ID
- DBS for TD
- Conditions
- Tardive Dyskinesia, Tardive Dystonia
- Keywords
- Deep Brain Simulation, Psychiatric, Side-effects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible to recruit and include a sufficient number of patients within the timeframe.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GGZ CentraalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Maastricht University
- Study start
- Jun 2015 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 25 Jun 2017 (estimated)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate stimulation | Active comparator | Device: GPi DBS with Medtronic electorde and Activa PC pulsegeneratorPatients 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 |
| Delayed stimulation | Sham comparator | Device: GPi DBS with Medtronic electorde and Activa PC pulsegeneratorPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPi DBS with Medtronic electorde and Activa PC pulsegeneratorAlso: DBS, GPi-DBSThe electric stimulation of 2 leads implanted in the Globus Pallidus internus | Device | Delayed stimulation, Immediate stimulation |
Primary outcome
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)
3 secondary outcomes
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
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
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
Results and safety
The study was stopped early (reason given: It was not possible to recruit and include a sufficient number of patients within the timeframe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter N van Harted, MD, PhD principal investigator
GGZ Centraal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPi DBS with Medtronic electorde and Activa PC pulsegenerator in people with Tardive Dyskinesia and Tardive Dystonia, run by GGZ Centraal at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was not possible to recruit and include a sufficient number of patients within the timeframe.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.