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Completed

NCT Number: NCT02263417

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

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Key information

Conditions

Dystonia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking union medical college hospital

Beijing, Beijing Municipality, 100032, China

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Deep Brain Stimulation (DBS) of Gpi

Device

Other names: Rechargeable Neurostimulator

Deep Brain Stimulation (DBS) of STN

Device

Other names: Rechargeable Neurostimulator

Primary outcomes

  1. Burke-Fahn-Marsden Scale (BFM)

    Time frame: Change from baseline in BMF at 1, 3 months and 6 months

Secondary outcomes

  1. Quality of life (SF-36)

    Time frame: Change from baseline in SF-36 at 1, 3 months and 6 months

  2. Psychiatric assessment (HADS-D and PANSS)

    Time frame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months

Sponsors and collaborators

Lead sponsor

Beijing Pins Medical Co., Ltd

Industry

Collaborators

  • Peking Union Medical College Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Oct 13, 2014
Registry last updated
Mar 1, 2023

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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