Anorexia NervosaEarly Phase 1NCT02263404
PINS Stimulator System to Treat Severe Anorexia Nervosa
A Early Phase 1 study testing Deep Brain Stimulation in people with Anorexia Nervosa, run by Beijing Pins Medical Co., Ltd.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Any contraindication to MRI or PET scanning.
- Body-mass index less than 13.
- Attended some other trials within one year.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called Rechargeable Neurostimulator
DBS Implant Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Related Preoccupations and Rituals
Measured: 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
Measured: Change from baseline at 3 months, 6 months and 12 months
Health Survey Short Form (SF-36)
Measured: Change from baseline at 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Li Luming, PhD, Study chair, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263404
- Sponsor's protocol ID
- PINS-004
- Status last verified
- Aug 2016
- First submitted
- 27 Sep 2014
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PINS Stimulator System to Treat Severe Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02263404
- Acronym / sponsor ID
- PINS-004
- Conditions
- Anorexia Nervosa
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationDBS Implant and stimulation Intervention: Device: Deep Brain Stimulation |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- Able to comply with all testing, follow-ups, and study appointments and protocols.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: Rechargeable NeurostimulatorDBS Implant Stimulation | Device | Deep Brain Stimulation |
Primary outcome
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
2 secondary outcomes
Hamilton Depression Rating Scale
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Luming, PhD study chair
Tsinghua University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deep Brain Stimulation in people with Anorexia Nervosa, run by Beijing Pins Medical Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia Fumin, PhD (+86 010-59361265, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.