NCT06752434

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
35mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Dec 2024Mar 2029

Study Start

First participant enrolled

December 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

December 22, 2024

Last Update Submit

December 22, 2024

Conditions

Dystonic Tremor

Keywords

Dystonic Tremordeep brain stimulationposterior subthalamic areasubthalamic nucleus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

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

    5 months

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

    7 months

  • 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 Beck depression inventory to 5 months

    5 months

  • +2 more secondary outcomes

Study Arms (2)

PSA-STN

EXPERIMENTAL

Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months.

Device: Deep brain stimulation

STN-PSA

EXPERIMENTAL

Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months.

Device: Deep brain stimulation

Interventions

Deep brain stimulationDEVICE

active DBS with optimal stimulating parameters

PSA-STNSTN-PSA

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Dianyou Li, MD, PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dianyou Li, MD, PhD

CONTACT

+0086-021-64370045ldy11483@rjh.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 22, 2024

First Posted

December 30, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

December 30, 2024

Record last verified: 2024-12

Locations

CN(1)