PINS Stimulator System to Treat Severe Anorexia Nervosa

October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deep Brain Stimulation
DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation
Device: Deep Brain Stimulation
DBS Implant Stimulation
Other Names:
  • Rechargeable Neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eating Disorder Related Preoccupations and Rituals
Time Frame: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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