Efficacy and Safety of Deep Brain Stimulation (DBS) of the Pallidal (GPi) in Patients With Tardive Dystonia
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ClinicalTrials.gov Identifier: NCT00331669 |
Recruitment Status : Unknown
Verified February 2009 by Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : May 31, 2006
Last Update Posted : March 4, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dystonia Movement Disorder | Procedure: deep brain stimulation | Phase 2 |
Deep brain stimulation (DBS) has been established as a new reversible, neurosurgical therapeutic option for patients suffering from disabling neurological movement disorders such as essential tremor and Parkinson´s disease. Recently, deep brain stimulation has been successfully applied in patients with primary generalized and segmental dystonia. Additionally, a number of case reports suggest that pallidal deep brain stimulation may also improve tardive dystonia, which may for instance result from the intake of neuroleptics and which is notoriously difficult to treat medically. The present study will investigate the effects of pallidal DBS using a double blind, randomized design (sham- versus verum-stimulation within a 3-months interval post implantation of the electrodes).
Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30%. However, in a recent study (Damier et al., Archives of General Psychiatry, 2007), 10 out of 10 showed a successful outcome of approximately 50% decrease on the extrapyramidal symptoms rating scale score. The exact one- sided lower 95% confidence limit would be 0.794 for this result. If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82% against a placebo effect of 30% success rate. For a placebo effect of 25% one needs 16+16 patients and for the placebo effect of 20% one needs 12+12 patients. We thus decided to reduce the sample size to 36- 32- 24 patients. It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above. The local ethical committee has approved this.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Randomized Trial on the Effects of Pallidal Deep Brain Stimulation for Tardive Dystonia |
Study Start Date : | May 2006 |
Estimated Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
device
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Procedure: deep brain stimulation
high frequency stimulation |
- Improvement of the motor scale of Burke-Fahn-Marsden-Dystonia Rating Scale via blinded video assessment 3 months after starting DBS in comparison to sham-stimulated patients [ Time Frame: 3 months ]
- AIMS [ Time Frame: 3 months ]
- Non-motor subscores of BMFDRS [ Time Frame: 3 months ]
- Visual analogue scales for both patients and treating physicians [ Time Frame: 3 months ]
- Quality of life (SF-36) [ Time Frame: 3 months ]
- Psychiatric assessment (HADS-D and PANSS) [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Operational criteria for tardive dystonia for > 18 months after cessation of neuroleptic exposure
- 18-75 years
- Relevant functional impairment in daily living activities
- BFMDRS > 8 or AIMS > 16
- Informed written consent
Exclusion Criteria:
- PANNS >60 (Schizophrenia)
- Hamilton-Score > 18 (Depression)
- MATTIS-Score <120 (Dementia)
- Preceding stereotactic neurosurgery
- Pronounced brain atrophy
- Increased bleeding risk
- Decreased immune status
- Botulinum Toxin treatment within the last 3 months

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): NCT00331669
Contact: Andreas R Kupsch, MD, PhD | xx49-30-450-50 ext 660103 | andreas.kupsch@charite.de | |
Contact: Andrea Kuehn, MD | xx49-30-450-50 ext 660203 | andrea.kuehn@charite.de |
Germany | |
Andreas Kupsch | Recruiting |
Berlin, Germany, 13353 | |
Contact: Andreas R Kupsch, MD, PhD xx49-30-450-50 ext 660103 andreas.kupsch@charite.de | |
Contact: Andrea Kuehn, MD xx49-30-450-50 ext 660203 andrea.kuehn@charite.de | |
Principal Investigator: Andreas R Kupsch, MD, PhD |
Principal Investigator: | Andreas R Kupsch, MD | Dpt. of Neurology, Augustenburger Platz 1, 13353 Berlin, Charite, Campus Virchow, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00331669 |
Other Study ID Numbers: |
DBS and tardive dystonia |
First Posted: | May 31, 2006 Key Record Dates |
Last Update Posted: | March 4, 2009 |
Last Verified: | February 2009 |
deep brain stimulation pallidum tardive dystonia |
randomized double blind multicenter |
Dystonia Dystonic Disorders Movement Disorders Tardive Dyskinesia Dyskinesias |
Neurologic Manifestations Nervous System Diseases Central Nervous System Diseases Dyskinesia, Drug-Induced |