PINS Stimulator System to Treat Severe Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

PINS Stimulator System to Treat Severe Anorexia Nervosa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02263404
• Other study ID #: PINS-004
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 27, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: +86 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Device:
• Deep Brain Stimulation
DBS Implant Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Hamilton Depression Rating Scale		Change from baseline at 3 months, 6 months and 12 months	Yes
Secondary	Health Survey Short Form (SF-36)		Change from baseline at 3 months, 6 months and 12 months	Yes