PINS Stimulator System to Treat Severe Anorexia Nervosa | NCT02263404

Studies
PINS Stimulator System to Treat Severe Anorexia Nervosa

NCT02263404

Sponsor

Beijing Pins Medical Co., Ltd

Status

Unknown status

Last Update Posted

Oct 14, 2016Estimated

Enrollment

16Estimated

Phase

Early Phase 1

Conditions

Anorexia Nervosa

Interventions

Deep Brain Stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Sep 27, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Name	Class
Beijing Tiantan Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Label	Type	Description	Intervention Names
Deep Brain Stimulation	Experimental	DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation	Device: Deep Brain Stimulation

Name	Type	Description	Arm Group Labels	Other Names
Deep Brain Stimulation	Device	DBS Implant Stimulation	Deep Brain Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative