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Deep Brain Stimulation for Patients With Chronic, Severe and Resistant Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT03168893
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Víctor Pérez, Parc de Salut Mar

Brief Summary:
Deep brain stimulacion (DBS) clinical study in the subcallosal cingulate (CSG) and accumbens nucleus (NAc) for 8 patients with treatment-refractory, cronic and severe anorexia nervosa (AN) patients. The main objective is to show efficacy and safety. Studies show that SSG and NAc are strategical targets in the pathophysiology and the hypothetical surgical treatment in AN patients. The patients distribution (4 patients in each target) it will made by the AN type and the comorbidity associated, the reasons are: 1- It is well known the comorbidity treatment imoportance in the AN evolution, 2- The two differentes types of AN have differents clinical behaviour and prognosis, 3- Studies show efficacy in TOC and DM patients with NAc DBS and in DM patients with CSG DBS. The main variable is BMI. After a 6 months stabilization evaluation phase will be followed (only in patients that have increase 10% BMI) by a double-bind, crossover phase, where patients will receive 3 months with stimulation turned on and 3 month with turned off. All patients will have a 12 months follow up. The study secondary objectives are to know the relation btween the stimulacion answer (increase 10% BMI) and the differents variables, specially AN type, associated cormobidity, selected target and preoperative MRI tractography study.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Device: Deep brain stimulation ON Device: Deep brain stimulation OFF Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation on the Subgenual Cingulate and Accumbens Nucleus for Patients With Chronic, Severe and Resistant Anorexia Nervosa
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : December 17, 2017
Estimated Study Completion Date : May 17, 2020

Arm Intervention/treatment
Experimental: Deep brain stimulation ON
Surgical procedure is necessary.In surgery, two cerebral electrodes (either in the Subgenual cingulate or in the Accumbens Nucleus) are connected to a subcutaneous generator at abdominal fat level, under general anesthesia. The patient will initiate the stimulation prior to discharge . At 6 months follow up, Deep brain stimulation continue 3 months more activated, patient and psychiatrist don´t know
Device: Deep brain stimulation ON
Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is activated
Other Name: Deep Brain Stimulation: Infinity model device (ON)

Experimental: Deep brain stimulation OFF
Surgical procedure is necessary.In surgery, two cerebral electrodes (either in the Subgenual cingulate or in the Accumbens Nucleus) are connected to a subcutaneous generator at abdominal fat level, under general anesthesia. The patient will initiate the stimulation prior to discharge . At 6 months follow up, Deep brain stimulation is stopped during 3 months , patient and psychiatrist don´t know
Device: Deep brain stimulation OFF
Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is not activated
Other Name: Deep Brain Stimulation: Infinity model device (OFF)




Primary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: From baseline till 12 months ]
    BMI will be measured monthly from baseline till 12 months. Data will be compared with BMI in the beginning of the open label period


Secondary Outcome Measures :
  1. Adverse events during the study [ Time Frame: From baseline till 12 months ]
  2. Psychiatric comorbidity [ Time Frame: From baseline till 12 months ]
    Psychiatric comorbidity will be measured monthly from baseline till 12 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(All criteria for inclusion must be met)

  1. Age between 18-60 years
  2. Diagnosis of AN, both restrictive type and compulsion / purge type defined by the DSM-V-TR
  3. Chronicity: minimum of 10 years of illness.
  4. Resistance to treatment, shown by one or both of the following situations:

    A. That of the multiple treatments performed, at least 1 is an intensive treatment (hospitalization or day hospital), with one or more of the following results:

    • I have not been able to finish the treatment.
    • That it has finished but with little or no answer.
    • That in spite of having finished it, and of having answered, Has found a subsequent relapse in the first six months. B. Clinical situation of medical instability, accompanied by refusal to participate in any treatment program and including at least 1 episode of admission for involuntary feeding.
  5. Extremely serious (BMI less than 15), or severe (BMI between 15-15,99)
  6. Ability to sign informed consent
  7. Ability to undergo all tests and follow-ups of the study

Exclusion Criteria:

  1. BMI less than 13 at the time of recruitment for the study.
  2. Psychosis in the present moment or in the past.
  3. Current neurological disease.
  4. Substance or alcohol abuse and dependence in the last year.
  5. Contraindications to perform a brain MRI
  6. Presence of cardiac arrhythmias or other cardiac, respiratory, renal or endocrine affections, as a result of AN or not, that carries risk for the surgical procedure.
  7. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168893


Contacts
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Contact: Gloria Villalba Martínez, Doctor 034 620305721 gloriavillalbamartinez@gmail.com

Locations
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Spain
Gloria Villalba Martinez Recruiting
Barcelona, Spain, 08003
Contact: gloria villalba martinez, Dr    34620305721    gloriavillalbamartinez@gmail.com   
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Study Director: Gloria Villalba Martínez, Doctor Parc de Salut Mar

Publications of Results:

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Responsible Party: Víctor Pérez, PhD MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03168893     History of Changes
Other Study ID Numbers: ECP-AN-2016-01
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Víctor Pérez, Parc de Salut Mar:
deep brain stimulation
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders