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

Beijing Pins Medical

Status and phase: Completed; Phase 4

Conditions: Dystonia

Treatments: Device: Deep Brain Stimulation (DBS) of STN; Device: Deep Brain Stimulation (DBS) of Gpi

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02263417

PINS-005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Deep Brain Stimulation

Active Comparator group

Description:

Stimulation is on

Treatment:

Device: Deep Brain Stimulation (DBS) of Gpi

Device: Deep Brain Stimulation (DBS) of STN

Placebo

Sham Comparator group

Description:

Stimulation is off

Treatment:

Device: Deep Brain Stimulation (DBS) of Gpi

Device: Deep Brain Stimulation (DBS) of STN