Dystonic Tremor
Conditions
Keywords
Dystonic Tremor, deep brain stimulation, posterior subthalamic area, subthalamic nucleus
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDeep brain stimulation
active DBS with optimal stimulating parameters
Sponsors
Suzhou Sceneray Medical Co. , Ltd
Beijing Pins Medical Co., Ltd
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with dystonic tremor based on the MDS 2018 consensus * Duration of DT symptoms: ≥3 years of motor symptoms * If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent * Good compliance and written informed consent
Exclusion criteria
* Any intracranial abnormalities that would prevent DBS surgery * Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders) * Severe cognitive impairment, MOCA score \<24 * Any current substance or alcohol abuse according to DSM-V criteria * Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints * Any terminal illness with a life expectancy of \<1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months | 5 months |
| Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months | 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Mini-Mental Status Exam to 5 months | 5 months |
| Change from baseline Mini-Mental Status Exam to 7 months | 7 months |
| Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months | 5 months |
| Change from baseline Beck depression inventory to 7 months | 7 months |
| Adverse events | up to 12 months after surgery |
| Change from baseline Beck depression inventory to 5 months | 5 months |
| Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months | 7 months |
Countries
China
Contacts
Primary ContactDianyou Li, MD, PhD
Outcome results
None listed