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NCT Number: NCT06752434

PSA Versus STN DBS for DT

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Dianyou Li, MD,PhD

CONTACT

[email protected]

+0086-021-64370045

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

active DBS with optimal stimulating parameters

Primary outcomes

  1. Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months

    Time frame: 5 months

  2. Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months

    Time frame: 7 months

Secondary outcomes

  1. Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months

    Time frame: 5 months

  2. Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months

    Time frame: 7 months

  3. Change from baseline Mini-Mental Status Exam to 5 months

    Time frame: 5 months

  4. Change from baseline Mini-Mental Status Exam to 7 months

    Time frame: 7 months

  5. Change from baseline Beck depression inventory to 5 months

    Time frame: 5 months

  6. Change from baseline Beck depression inventory to 7 months

    Time frame: 7 months

  7. Adverse events

    Time frame: up to 12 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Dianyou Li, MD, PhD

CONTACT

[email protected]

+0086-021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Beijing Pins Medical Co., Ltd
  • Suzhou Sceneray Medical Co. , Ltd

Registry information

Official study 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

Acronym: PSA-STN

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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