Back to resultsPINS Stimulator System to Treat Severe Anorexia Nervosa
Primary Purpose
Anorexia Nervosa
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation
Arm Description
DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation
Outcomes
Primary Outcome Measures
Eating Disorder Related Preoccupations and Rituals
Secondary Outcome Measures
Hamilton Depression Rating Scale
Health Survey Short Form (SF-36)
Full Information
NCT ID
NCT02263404
First Posted
September 27, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02263404
Brief Title
PINS Stimulator System to Treat Severe Anorexia Nervosa
Official Title
PINS Stimulator System to Treat Severe Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
Rechargeable Neurostimulator
Intervention Description
DBS Implant Stimulation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Time Frame
Change from baseline at 3 months, 6 months and 12 months
Title
Health Survey Short Form (SF-36)
Time Frame
Change from baseline at 3 months, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
+86 010-59361265
Email
pins_medical@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
PINS Stimulator System to Treat Severe Anorexia Nervosa
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