PINS Stimulator System to Treat Severe Anorexia Nervosa

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Anorexia Nervosa

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02263404

PINS-004

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Deep Brain Stimulation

Experimental group

Description:

DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation

Treatment:

Device: Deep Brain Stimulation