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Loss of Control EatingDBSLOCNCT03868670

Responsive Neurostimulation For Loss Of Control Eating

A study testing responsive neurostimulation in people with Loss of Control Eating and Obesity, Morbid, run by University of Pennsylvania at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility. Read more about this study

Who is it for?
Ages 22 to 70 years
Conditions the study is for
Loss of Control Eating, Obesity, Morbid
What is being tested?
responsive neurostimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesUnited States
Study dates
10 Apr 2019to 1 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 22 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI 35-60 kg/m2
  • Failure of at least one pharmacological agent intended for weight loss or binge eating disorder (select glucagon-like-peptide 1 [GLP-1] receptor agonists for the treatment of type 2 diabetes, which induce clinically meaningful weight loss [i.e., >2% baseline weight], qualify as agents intended for weight loss, as do glucose-dependent insulinotropic polypeptide [GIP]/GLP-1 agonists)
  • Failure of at least one form of behavioral therapy, such as weight loss therapy and cognitive behavioral therapy (minimum cumulative trial of 6 months)
  • Failure of gastric bypass surgery or sleeve gastrectomy surgery
  • Assessment by the study site's bariatric surgeon to rule out technical explanations for suboptimal outcome with an upper GI series within 6 months prior to consent (i.e. a pre-study referral assessment) or prior to surgery during the screening phase.
  • Presence of LOC over eating (≥4 LOC episodes per week or ≥16 episodes per month (i.e. 28 days)), as reported on the ELOCS or the EDE interview
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  • Any medical (including psychiatric) conditions must be monitored actively by appropriate discipline and stable for the past 6 months. Related therapies or medications should be held stable for the study duration.
  • Surgical suitability confirmed by a psychiatric examination.
  • Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
  • Subject is willing and able to complete signaled EMA assessments.
  • Adequate social support (e.g. stable housing, identified family member or close friend as emergency contact) without acute or subacute psychosocial stressors based on screening interview
  • Premenopausal women must agree to use acceptable methods of birth control.
  • Participants provide voluntary, decisionally capable, and appropriately informed consent. - Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
  • Participant has no immediate plan for relocation beyond 6 hours of the study site.
  • Proficiency with the English language.

Who cannot join

  • Subject has an implanted medical device that delivers electrical energy to the brain.
  • Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
  • Subject requires diathermy treatments.
  • Subject requires transcranial magnetic stimulation (TMS) or electroconvulsive therapy.
  • Subject is likely to require repeat magnetic resonance imaging (MRI) after implant of the RNS Neurostimulator and Leads.
  • Subject is unable to fit into Computerized Tomography (CT) scanner (500lb upper weight limit for CT scanner).
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  • Subject is pregnant or intends to become pregnant during the course of the study.
  • Subject is participating in a therapeutic investigational drug or device study.
  • Subject has medical contraindications for surgery including but not limited to severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, or an acute infectious process.
  • Subject has evidence of neurological disorders, e.g. seizure disorder, multiple sclerosis, severe acquired brain injury, severe brain atrophy, subdural hematoma, history of hemorrhagic stroke, or other clinically relevant abnormality on preoperative imaging.
  • Subject has a current physical or medical condition that could affect eating behavior (e.g., cancer, pregnancy).
  • Subject is actively using medication known to affect eating (e.g., appetite suppressants).
  • Subject has a clinically significant or unstable psychiatric condition based on psychiatric screening interview.
  • Subject has a clinical diagnosis (past or present) of severe anxiety disorder, severe major depression, psychosis, or anorexia based on diagnostic interview.
  • Subject has any lifetime history of suicide attempt, intent or engagement in other forms of self-harm behaviors (e.g. cutting).
  • Subject has a history of drug abuse or dependence, including nicotine and alcohol, within the preceding 24 months.
  • Subject has current use of alcohol at the rate of > 14 drinks per week or > 4 drinks per occasion or any diagnosis of substance abuse/dependence disorder based on DSM-5.
  • There is evidence of incipient dementia or cognitive impairment on Neuropsychological assessment by any score on memory, executive functioning, intellectual functioning, language, or visuospatial domains falling 2SD below the normative mean.
  • There is evidence of comprehension difficulties (Token Test <36).
  • Subject is unable to provide informed consent to treatment.
  • Obesity is secondary to another medical condition, a medication side effect, or a genetic syndrome.
  • Subject is a candidate for revision of their bariatric surgery due to anatomical or medical co-morbidities that could be addressed. Of note, revision of a sleeve gastrectomy to a gastric bypass for to reverse weight regain alone is less frequently considered a worthwhile effort as the average weight loss of such a revision is about a 10% weight loss. Thus, patients who have a sleeve and meet the Reinhold classification will be included in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107

  • Stanford University

    Stanford, California, 94301

Other trials in United States

About this study

The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.

Read the detailed description

This is a single site, early feasibility study to support development of a novel therapeutic approach for utilizing the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation (NAc- RNS) to ameliorate loss of control over (LOC) eating in persons with treatment-refractory obesity, specifically those who have failed gastric bypass surgery or sleeve gastrectomy surgery. The primary objectives are to assess the safety \& feasibility \& potential efficacy of the medical device named the NeuroPace RNS® System.

Being tested
responsive neurostimulation
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • responsive neurostimulationDevice

    The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.

Study groups in NCT03868670
Study groupRoleWhat they receive
Responsive NeurostimulationExperimentalSurgical arm. Patients expected to receive treatment.
Receives: Device: responsive neurostimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]

    Safety of the RNS System and NAc stimulation through evaluation of AE's graded as "related" (vs. not related) to the intervention that will be graded based on severity.

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

    Measured: 5 years

  2. Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week

    The primary efficacy endpoint will be assessed by at least 50% of subjects exhibiting a decrease in the number of LOC episodes per week. LOC episodes will be assessed by the EDE Interview.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start10 Apr 2019
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03868670
Sponsor's protocol ID
IRB-46563
Acronym
DBSLOC
Status last verified
Jul 2026
First submitted
14 Feb 2019
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Shivacharan RS, Rolle CE, Barbosa DAN, Cunningham TN, Feng A, Johnson ND, Safer DL, Bohon C, Keller C, Buch VP, Parker JJ, Azagury DE, Tass PA, Bhati MT, Malenka RC, Lock JD, Halpern CH. Pilot study of responsive nucleus accumbens deep brain stimulation for loss-of-control eating. Nat Med. 2022 Sep;28(9):1791-1796. doi: 10.1038/s41591-022-01941-w. Epub 2022 Aug 29.

    PubMed 36038628

Questions about this trial

What is this clinical trial studying?

A study testing responsive neurostimulation in people with Loss of Control Eating and Obesity, Morbid, run by University of Pennsylvania at 2 sites in United States.

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 15 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability] (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868670, which also lists 1 linked publication.

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 29 Jul 2026.

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