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

Phase 4

Completed

• Conditions: Dystonia
• Interventions: Device: Deep Brain Stimulation (DBS) of Gpi; Device: Deep Brain Stimulation (DBS) of STN

• Registration Number: NCT02263417
• Lead Sponsor: Beijing Pins Medical Co., Ltd

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-09-27
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Study Start: 2015-07
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation (DBS) of Gpi	Stimulation is on
Deep Brain Stimulation	Deep Brain Stimulation (DBS) of STN	Stimulation is on
Placebo	Deep Brain Stimulation (DBS) of STN	Stimulation is off
Placebo	Deep Brain Stimulation (DBS) of Gpi	Stimulation is off

Primary Outcome Measures

Name	Time	Method
Burke-Fahn-Marsden Scale (BFM)	Change from baseline in BMF at 1, 3 months and 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Beijing, China