An interventional study of Deep brain stimulation in Dystonic Tremor, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
158 studies on the registry are indexed under Tremor; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 33 across 109 interventional studies indexed under Tremor.
Browse Tremor studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months.
Device: Deep brain stimulation
Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months.
Device: Deep brain stimulation
active DBS with optimal stimulating parameters
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
Time frame: 5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
Time frame: 7 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months
Time frame: 5 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months
Time frame: 7 months
Change from baseline Mini-Mental Status Exam to 5 months
Time frame: 5 months
Change from baseline Mini-Mental Status Exam to 7 months
Time frame: 7 months
Change from baseline Beck depression inventory to 5 months
Time frame: 5 months
Change from baseline Beck depression inventory to 7 months
Time frame: 7 months
Adverse events
Time frame: up to 12 months after surgery
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