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ObesityPhase 1BLESSNCT02232919

Deep Brain Stimulation for Human Morbid Obesity

A Phase 1 study testing Deep Brain Stimulation in people with Obesity, run by Hospital do Coracao at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as the psychological effects and related health-care costs, are well established in the medical literature. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
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
6 participants
Where
1 siteBrazil
Study dates
Apr 2014to Apr 2016
Phase
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body Mass Index [BMI] >40 kg/m2. BMI definition = weight [Kg] / height [m]2
  • Failed diet, exercise, behavior, and pharmacotherapy to control body weight.

Who cannot join

  • Cancer requiring treatment in the past five years, with the exception of cancers which have been cured or, in the opinion of the investigator, carry a good prognosis [for example, non melanoma skin cancer].
  • Infectious disease [e.g., HIV or active tuberculosis].
  • Cardiovascular disease:
  • Hospitalization for treatment of heart disease in the past 6 months. ii. New York Heart Association Functional Class >2. iii. Left bundle branch block on EKG. iv. Third degree atrioventricular block on EKG. v. Uncontrolled hypertension [average systolic blood pressure of >160 mmHg or diastolic blood pressure >95 mmHg on both screening visits].
  • Pulse rate >95 beats per minute on both screening visits. vii. Total serum cholesterol >300 mg/dL. viii. Stroke or transient ischemic attack in the past 6 months.
  • Gastrointestinal disease:
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  • Chronic hepatitis or cirrhosis. ii. Episode of alcoholic hepatitis or alcoholic pancreatitis. iii. Inflammatory bowel disease requiring treatment in the past year. iv. Recent or significant abdominal surgery [e.g., gastrectomy or gastric bypass].
  • Renal disease:
  • Serum creatinine >1.5 mg/dL. ii. Urine protein>2+ on dipstick at screening and or 24-hour urinary excretion of albumin>500 mg/day.
  • Lung disease:
  • Chronic obstructive airway disease or asthma requiring daily therapy. ii. Use of home oxygen.
  • Endocrine disease:
  • Diabetes mellitus. ii. Hyperlipidemia with triacylglycerol >500 mg/dL. iii. Hypothyroidism, hyperthyroidism. iv. Hypopituitarism. v. Hypogonadism.
  • Psychological Disease:
  • Major clinical depression. ii. Active psychiatric disorders. iii. Schizophrenia.
  • Hematology i. Anemia [hematocrit <36.0%]. ii. Bleeding disorders, thrombocytopenia, thrombocytosis.
  • Conditions or behaviors likely to affect the conduct of the study:
  • Unable or unwilling to give informed consent. ii. Unable to communicate with the clinic staff. iii. Weight loss >10% in the past 6 months. iv. Unable to walk 0.25 miles in 10 minutes. v. Behavioral disorder which, in the opinion of the investigator, would impede conduct of the study.
  • Excessive alcohol intake, use of illicit drugs.
  • Conditions related to medications:
  • Psychoactive agents. ii. Monoamine oxidase inhibitors [e.g., phenelzine, procarbazine, selegiline, furazolidone].
  • Antidepressants [e.g., lithium, fluoxetine, sertraline, nefazodone, paroxetine, venlafaxine].
  • Any other medication that, in the opinion of the investigator, may pose harm to the subject.
  • Seizure disorders.
  • Receiving anticoagulation medications or likely to need anticoagulation in the foreseeable future.
  • Subject is not a surgical candidate.
  • Lack of social support.
  • Inability to comply with testing and follow-up visit requirements defined by the Study Protocol.
  • Subject has another implanted device or metallic object [e.g., cardiac demand pacemakers, aneurysm clips, cochlear implant, spinal cord stimulator, etc].
  • Subject has a medical condition that might require repeat MRIs.
  • Subject has concurrent infection.
  • Subject has any medical condition contraindicating a chronically implanted device.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital do Coracao

    São Paulo, São Paulo, 04005-000

Other trials in Brazil

About this study

Official title: Hypothalamus Deep Brain Stimulation for Human Morbid Obesity: Feasibility Trial

The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as the psychological effects and related health-care costs, are well established in the medical literature. Lifestyle and dietary patterns remain critical factors modulating long-term weight control of morbidly obese individuals (bodymass index ≥ 40). Various dietary, pharmacological, and behavioral interventions have largely failed as therapies, often necessitating surgery as the last treatment option. Long term results of bariatric surgery suggest that sustained and substantial weight loss can decrease morbidity related to obesity secondary complications such as diabetes type 2 and cancers, enhancing the role of surgery for morbidly obese subjects. However the adverse effects of bariatric surgery are considerable and impact on quality of life. Its long-term failure rates and complications call for novel and effective long-term therapies, such as neurosurgical interventions.

The investigators now propose to enhance our targeting capabilities in a feasibility study of low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six morbidly obese patients. After successful targeting, DBS stimulation parameters will be systematically evaluated and individually optimized at three-month intervals over a one-year stimulation period. Detailed recording of side effects, weight changes, food intake patterns, metabolic changes, and behavioral evaluations will be obtained throughout the study.

Read the detailed description

Neuromodulation of metabolism and feeding behavior is at hand using modern systems of deep brain stimulation (DBS). It constitutes a minimally invasive approach for these challenging patients. The surgical procedure is reversible and proven to have acceptable side effects in the frail population of Parkinson's disease patients [Gorgulho, Hemorrhage and Infection]. Improvement of functional stereotactic surgery methods is necessary however to the challenge of implanting DBS electrodes in the hypothalamus. Recently, a case report of a patient with DBS implanted in the hypothalamus for treatment of morbid obesity who reported side effects related to memory appeared in the literature. The authors used the side effect findings to suggest the location of their implant as a site for treatment of Alzheimer's disease. This illustrates the need of betterment of our techniques of targeting in DBS surgery, especially for targets located in highly functional structures, such as the hypothalamus.

Conditions
Obesity
Being tested
Deep Brain Stimulation
Keywords
Deep Brain Stimulation
Medical subject headings
Obesity

What participants receive

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

  • Deep Brain StimulationDevice

    If subjects qualify with respect to protocol requirements, the Medtronic Activa system will be implanted with the leads placed bilaterally in the VMH.

    Adjustment of DBS parameters at the three months visit will be performed to improve efficacy when the goal of 3% body weight loss mark was not achieved during this period of continuous stimulation. Subjects will be seen monthly after discharge throughout the study period. At visits, safety will be assessed through blood/urine tests, blood pressure measurements, verbal interviews with the subjects and family, quarterly formal psychiatric tests as well as QOL scales.

    The determination of efficacy will be the within-group percent change in weight at the end of the DBS treatment period compared to baseline.

Study groups in NCT02232919
Study groupRoleWhat they receive
Deep Brain StimulationExperimentalThe design of this translation trial is a single-center, single cohort, open-label and non-masked study. The aim is to evaluate tolerability of chronic low-frequency electrical stimulation of the VMH, while achieving weight loss in morbidly obese subjects. The subjects must have a body-mass index [BMI] greater than 40, and no obesity co-morbidities, such as diabetes or cardiopulmonary abnormalities. Up to six subjects will be implanted in this protocol.
Receives: Device: Deep Brain Stimulation

What is being measured

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

  1. Identification of possible adverse events related to stimulation of the VMH

    To identify potential side effects of continuous electrical stimulation of the VMH and optimize electrophysiological parameters to avoid these side effects in morbidly obese subjects.

    Measured: 12 months

Secondary outcomes (3)

  1. Body Weight

    To determine if continuous VMH-DBS will lead to weight loss in morbidly obese subjects. Baseline measurements of body weight [kg, lb] will be recorded on 3 different occasions prior to DBS implantation. The baseline weight will be considered the arithmetic mean of these measurements. Body weight will be recorded at every follow-up visit.

    Measured: 12 months

  2. Body Composition

    To determine if continuous electrical stimulation of the VMH will lead to changes in body composition. Measurements of body composition will be evaluated by Dual-Energy Xray Absorptiometry [DEXA] at baseline and at 3 month intervals.

    Measured: 12 months

  3. Food Intake.

    To determine if VMH-DBS will cause decreased food intake. Subjects will complete a questionnaire during the monthly visit assisted by the study coordinator. Data reflecting food quality and quantity will be compiled for analysis and correlation with the other parameters obtained in the study.

    Measured: 12 months

Timeline

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

  1. First posted5 Sep 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02232919
Sponsor's protocol ID
230/2012
Acronym
BLESS
Status last verified
Sep 2016
First submitted
21 Aug 2014
Last updated
29 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • De Salles AAF, Barbosa DAN, Fernandes F, Abucham J, Nazato DM, Oliveira JD, Cury A, Biasi A, Rossi R, Lasagno C, Bueno PT, Santos RHN, Damiani LP, Gorgulho AA. An Open-Label Clinical Trial of Hypothalamic Deep Brain Stimulation for Human Morbid Obesity: BLESS Study Protocol. Neurosurgery. 2018 Oct 1;83(4):800-809. doi: 10.1093/neuros/nyy024.

    PubMed 29538761

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deep Brain Stimulation in people with Obesity, run by Hospital do Coracao at 1 site in Brazil.

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 2 inclusion and 32 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: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Identification of possible adverse events related to stimulation of the VMH (time frame: 12 months). 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 NCT02232919, 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 Sep 2016.

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