PINS Stimulator System to Treat Severe Anorexia Nervosa

NCT02263404 | Unknown Early Phase 1 DMC

• 1 other identifier: PINS-004
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

DBS Implant Stimulation

Also known as: Rechargeable Neurostimulator

Deep Brain Stimulation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or male patients aged 20-60 years.
• Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
• 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.
• Able to comply with all testing, follow-ups, and study appointments and protocols.

You may not qualify if:

• Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
• Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
• Patients with serious infectious disease.
• Patients with history of serious neurological or psychiatrical diseases.
• Person with history of HIV infection or serious malnutrition.
• Dependent upon and addicted to multiple drugs.
• Any contraindication to MRI or PET scanning.
• Body-mass index less than 13.
• Attended some other trials within one year.

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead
• Beijing Tiantan Hospital: collaborator

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Li Luming, PhD

  Tsinghua University

  STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

+86 010-59361265; pins_medical@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: October 13, 2014
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-08