PSA Versus STN DBS for DT

Last updated: December 22, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonia

Treatment

Deep brain stimulation

Clinical Study ID

NCT06752434
DTPSASTN
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 28days prior to informed consent

  • Good compliance and written informed consent

Exclusion

Exclusion Criteria:

  • Any intracranial abnormalities that would prevent DBS surgery

  • Any significant mental illness that might affect the subject's ability to complywith the study protocol requirements (e.g., bipolar disorder, schizophrenia, mooddisorders 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 movementdisorder treatment involving intracranial surgery or device implantation; anyhistory of hemorrhagic stroke; any significant medical condition that mightinterfere with the study procedures or could confound the assessment of studyendpoints

  • Any terminal illness with a life expectancy of <1 year

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Deep brain stimulation
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

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

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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