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

Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263417
• Other study ID #: PINS-005
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: June 2020

Study information

• Verified date: February 2023
• Source: Beijing Pins Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Device:
• Deep Brain Stimulation (DBS) of Gpi

• Deep Brain Stimulation (DBS) of STN

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burke-Fahn-Marsden Scale (BFM)		Change from baseline in BMF at 1, 3 months and 6 months
Secondary	Quality of life (SF-36)		Change from baseline in SF-36 at 1, 3 months and 6 months
Secondary	Psychiatric assessment (HADS-D and PANSS)		Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months