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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02263417

Enrollment

Registered

2014-10-13

Start date

2015-07-31

Completion date

2020-06-30

Last updated

2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia

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.

Interventions

DEVICEDeep Brain Stimulation (DBS) of Gpi

DEVICEDeep Brain Stimulation (DBS) of STN

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026