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

Overview

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

• Device Deep brain stimulation
  active DBS with optimal stimulating parameters

Primary outcome measures

• 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]

Secondary outcome measures (7)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06752434 · DTPSASTN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗