PINS Stimulator System to Treat Severe Anorexia Nervosa

Early Phase 1

• Conditions: Anorexia Nervosa
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02263404
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-27
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation	DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation

Primary Outcome Measures

Name	Time	Method
Eating Disorder Related Preoccupations and Rituals	Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Change from baseline at 3 months, 6 months and 12 months
Health Survey Short Form (SF-36)	Change from baseline at 3 months, 6 months and 12 months