Clinical trial NCT06752434: PSA Versus STN DBS for DT
Official title: Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dystonic Tremor
Keywords: Dystonic Tremor
deep brain stimulation
posterior subthalamic area
subthalamic nucleus
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou Sceneray Medical Co. , Ltd
name: Beijing Pins Medical Co., Ltd
First posted: 2024-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
timeFrame: 5 months
measure: Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
timeFrame: 7 months
Secondary outcomes:
measure: Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months
timeFrame: 5 months
measure: Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months
timeFrame: 7 months
measure: Change from baseline Mini-Mental Status Exam to 5 months
timeFrame: 5 months
measure: Change from baseline Mini-Mental Status Exam to 7 months
timeFrame: 7 months
measure: Change from baseline Beck depression inventory to 5 months
timeFrame: 5 months
measure: Change from baseline Beck depression inventory to 7 months
timeFrame: 7 months
measure: Adverse events
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Dianyou Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: