PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Obesity

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02254395

PINS-010

Details and patient eligibility

About

The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is aged 18 to 65.
2. Body Mass Index [BMI] >40 kg/m2.

Exclusion criteria

1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of < 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Deep Brain Stimulation

Experimental group

Description:

Stimulation is on.

Treatment:

Device: Deep Brain Stimulation

Placebo

Sham Comparator group

Description:

Sham Stimulation: Stimulation is off.

Treatment:

Device: Deep Brain Stimulation