A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

February 27, 2023 updated by: Beijing Pins Medical Co., Ltd

The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia

The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is aged 18 to 75 years old, male or female.
  2. Diagnosed with cervical dystonia by a movement disorders neurologist.
  3. Has cervical dystonia alone, not generalized or multifocal.
  4. Has had adequate trials of medical therapy.

Exclusion Criteria:

  1. Cognitive impairment.
  2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
  3. Medical conditions precluding general anaesthetic or surgery.
  4. Unstable psychiatric disease.
  5. Previous brain lesions to treat cervical dystonia.
  6. Attended some other trials within three month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deep Brain Stimulation
Stimulation is on
Device: Deep Brain Stimulation (DBS) of Gpi
Other Names:
  • Rechargeable Neurostimulator
Device: Deep Brain Stimulation (DBS) of STN
Other Names:
  • Rechargeable Neurostimulator
Sham Comparator: Placebo
Stimulation is off
Device: Deep Brain Stimulation (DBS) of Gpi
Other Names:
  • Rechargeable Neurostimulator
Device: Deep Brain Stimulation (DBS) of STN
Other Names:
  • Rechargeable Neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Burke-Fahn-Marsden Scale (BFM)
Time Frame: Change from baseline in BMF at 1, 3 months and 6 months
Change from baseline in BMF at 1, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life (SF-36)
Time Frame: Change from baseline in SF-36 at 1, 3 months and 6 months
Change from baseline in SF-36 at 1, 3 months and 6 months
Psychiatric assessment (HADS-D and PANSS)
Time Frame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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