PINS Stimulator System to Treat Severe Anorexia Nervosa

NCT ID: NCT02263404

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-12-31

Brief Summary

Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. The study will help patients with severe AN using DBS. Individuals with severe intractable AN will be eligible to take part in the study.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deep Brain Stimulation

DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

DBS Implant Stimulation

Interventions

Deep Brain Stimulation

DBS Implant Stimulation

Intervention Type: DEVICE

Other Intervention Names

Rechargeable Neurostimulator

Eligibility Criteria

Inclusion Criteria

1. Female or male patients aged 20-60 years.

2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).

3. Chronicity or treatment resistance shown by some or all of:

• A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment.
• A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding.
• A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
• Able to provide informed consent.

4. Able to comply with all testing, follow-ups, and study appointments and protocols.

Exclusion Criteria

1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.

2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.

3. Patients with serious infectious disease.

4. Patients with history of serious neurological or psychiatrical diseases.

5. Person with history of HIV infection or serious malnutrition.

6. Dependent upon and addicted to multiple drugs.

7. Any contraindication to MRI or PET scanning.

8. Body-mass index less than 13.

9. Attended some other trials within one year.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Central Contacts

Jia Fumin, PhD

Role: CONTACT

pins_medical@163.com

+86 010-59361265

Other Identifiers

PINS-004

Identifier Type: -

Identifier Source: org_study_id