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

NCT03168893 | Unknown DMC

• 1 other identifier: ECP-AN-2016-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI)

  BMI will be measured monthly from baseline till 12 months. Data will be compared with BMI in the beginning of the open label period

  From baseline till 12 months

Secondary Outcomes (2)

• Adverse events during the study

  From baseline till 12 months

• Psychiatric comorbidity

  From baseline till 12 months

Study Arms (2)

Deep brain stimulation ON

EXPERIMENTAL

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

Deep brain stimulation OFF

EXPERIMENTAL

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

Interventions

Deep brain stimulation ON DEVICE

Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is activated

Also known as: Deep Brain Stimulation: Infinity model device (ON)

Deep brain stimulation ON

Deep brain stimulation OFF DEVICE

Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is not activated

Also known as: Deep Brain Stimulation: Infinity model device (OFF)

Deep brain stimulation OFF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-60 years
• Diagnosis of AN, both restrictive type and compulsion / purge type defined by the DSM-V-TR
• Chronicity: minimum of 10 years of illness.
• 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.
• Extremely serious (BMI less than 15), or severe (BMI between 15-15,99)
• Ability to sign informed consent
• Ability to undergo all tests and follow-ups of the study

You may not qualify if:

• BMI less than 13 at the time of recruitment for the study.
• Psychosis in the present moment or in the past.
• Current neurological disease.
• Substance or alcohol abuse and dependence in the last year.
• Contraindications to perform a brain MRI
• 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.
• Pregnancy

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Gloria Villalba Martinez

Barcelona, 08003, Spain

RECRUITING

Related Publications (13)

• Hayes DJ, Lipsman N, Chen DQ, Woodside DB, Davis KD, Lozano AM, Hodaie M. Subcallosal Cingulate Connectivity in Anorexia Nervosa Patients Differs From Healthy Controls: A Multi-tensor Tractography Study. Brain Stimul. 2015 Jul-Aug;8(4):758-68. doi: 10.1016/j.brs.2015.03.005. Epub 2015 May 21.

  PMID: 26073966 RESULT

• Cleary DR, Ozpinar A, Raslan AM, Ko AL. Deep brain stimulation for psychiatric disorders: where we are now. Neurosurg Focus. 2015 Jun;38(6):E2. doi: 10.3171/2015.3.FOCUS1546.

  PMID: 26030702 RESULT

• Lipsman N, Lozano AM. Targeting emotion circuits with deep brain stimulation in refractory anorexia nervosa. Neuropsychopharmacology. 2014 Jan;39(1):250-1. doi: 10.1038/npp.2013.244. No abstract available.

  PMID: 24317325 RESULT

• Lipsman N, Woodside DB, Giacobbe P, Lozano AM. Neurosurgical treatment of anorexia nervosa: review of the literature from leucotomy to deep brain stimulation. Eur Eat Disord Rev. 2013 Nov;21(6):428-35. doi: 10.1002/erv.2246. Epub 2013 Jul 19.

  PMID: 23873668 RESULT

• Sun B, Liu W. Stereotactic surgery for eating disorders. Surg Neurol Int. 2013 Apr 17;4(Suppl 3):S164-9. doi: 10.4103/2152-7806.110668. Print 2013.

  PMID: 23682343 RESULT

• Oudijn MS, Storosum JG, Nelis E, Denys D. Is deep brain stimulation a treatment option for anorexia nervosa? BMC Psychiatry. 2013 Oct 31;13:277. doi: 10.1186/1471-244X-13-277.

  PMID: 24175936 RESULT

• Treasure J, Ashkan K. Deep brain stimulation for anorexia nervosa: a step forward. Eur Eat Disord Rev. 2013 Nov;21(6):507-8. doi: 10.1002/erv.2253. Epub 2013 Sep 20. No abstract available.

  PMID: 24115472 RESULT

• Lipsman N, Woodside B, Lozano AM. Evaluating the potential of deep brain stimulation for treatment-resistant anorexia nervosa. Handb Clin Neurol. 2013;116:271-6. doi: 10.1016/B978-0-444-53497-2.00022-X.

  PMID: 24112901 RESULT

• Benabid AL. Comment on 'Treatment of intractable anorexia nervosa with inactivation of the nucleus accumbens using stereotactic surgery'. Stereotact Funct Neurosurg. 2013;91(6):373. doi: 10.1159/000348279. Epub 2013 Oct 9. No abstract available.

  PMID: 24108085 RESULT

• Lipsman N, Woodside DB, Lozano AM. Deep brain stimulation for anorexia nervosa - authors' reply. Lancet. 2013 Jul 27;382(9889):306. doi: 10.1016/S0140-6736(13)61631-1. No abstract available.

  PMID: 23890039 RESULT

• McLaughlin NC, Didie ER, Machado AG, Haber SN, Eskandar EN, Greenberg BD. Improvements in anorexia symptoms after deep brain stimulation for intractable obsessive-compulsive disorder. Biol Psychiatry. 2013 May 1;73(9):e29-31. doi: 10.1016/j.biopsych.2012.09.015. Epub 2012 Nov 3. No abstract available.

  PMID: 23128051 RESULT

• Wu H, Van Dyck-Lippens PJ, Santegoeds R, van Kuyck K, Gabriels L, Lin G, Pan G, Li Y, Li D, Zhan S, Sun B, Nuttin B. Deep-brain stimulation for anorexia nervosa. World Neurosurg. 2013 Sep-Oct;80(3-4):S29.e1-10. doi: 10.1016/j.wneu.2012.06.039. Epub 2012 Jun 25.

  PMID: 22743198 RESULT

• Perez V, Villalba-Martinez G, Elices M, Manero RM, Salgado P, Gines JM, Guardiola R, Cedron C, Polo M, Delgado-Martinez I, Conesa G, Medrano S, Portella MJ. Cognitive and quality-of-life related factors of body mass index (BMI) improvement after deep brain stimulation in the subcallosal cingulate and nucleus accumbens in treatment-refractory chronic anorexia nervosa. Eur Eat Disord Rev. 2022 Jul;30(4):353-363. doi: 10.1002/erv.2895. Epub 2022 Mar 23.

  PMID: 35322504 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Gloria Villalba Martínez, Doctor

  Parc de Salut Mar

  STUDY DIRECTOR

Central Study Contacts

Gloria Villalba Martínez, Doctor

CONTACT

034 620305721; gloriavillalbamartinez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: May 23, 2017
• Primary Completion: March 17, 2020
• Study Completion: December 17, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)