A Randomized Trial of Deep Brain Stimulation to the Subcallosal Cingulate and Nucleus Accumbens in Patients with Treatment-Refractory, Chronic, and Severe Anorexia Nervosa: Initial Results at 6 Months of Follow Up

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Abstract

Background: The main objective of this study was to assess the safety and efficacy of deep brain stimulation (DBS) in patients with severe anorexia nervosa (AN). Methods: Eight participants received active DBS to the subcallosal cingulate (SCC) or nucleus accumbens (NAcc) depending on comorbidities (affective or anxiety disorders, respectively) and type of AN. The primary outcome measure was body mass index (BMI). Results: Overall, we found no significant difference ( p = 0.84) between mean preoperative and postoperative (month 6) BMI. A BMI reference value (BMI-RV) was calculated. In patients that received preoperative inpatient care to raise the BMI, the BMI-RV was defined as the mean BMI value in the 12 months prior to surgery. In patients that did not require inpatient care, the BMI-RV was defined as the mean BMI in the 3-month period before surgery. This value was compared to the postoperative BMI (month 6), revealing a significant increase ( p = 0.02). After 6 months of DBS, five participants showed an increase of ≥10% in the BMI-RV. Quality of life was improved ( p = 0.03). Three cases presented cutaneous complications. Conclusion: DBS may be effective for some patients with severe AN. Cutaneous complications were observed. Longer term data are needed.

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Most cited references 34

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Deep brain stimulation: current challenges and future directions

Andres Lozano, Nir Lipsman, Hagai Bergman … (2019)

The clinical use of deep brain stimulation (DBS) is among the most important advances in the clinical neurosciences in the past two decades. As a surgical tool, DBS can directly measure pathological brain activity and can deliver adjustable stimulation for therapeutic effect in neurological and psychiatric disorders correlated with dysfunctional circuitry. The development of DBS has opened new opportunities to access and interrogate malfunctioning brain circuits and to test the therapeutic potential of regulating the output of these circuits in a broad range of disorders. Despite the success and rapid adoption of DBS, crucial questions remain, including which brain areas should be targeted and in which patients. This Review considers how DBS has facilitated advances in our understanding of how circuit malfunction can lead to brain disorders and outlines the key unmet challenges and future directions in the DBS field. Determining the next steps in DBS science will help to define the future role of this technology in the development of novel therapeutics for the most challenging disorders affecting the human brain.

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The outcome of anorexia nervosa in the 20th century.

Hans-Christoph Steinhausen (2002)

The present review addresses the outcome of anorexia nervosa and whether it changed over the second half of the 20th century. A total of 119 study series covering 5,590 patients suffering from anorexia nervosa that were published in the English and German literature were analyzed with regard to mortality, global outcome, and other psychiatric disorders at follow-up. There were large variations in the outcome parameters across studies. Mortality estimated on the basis of both crude and standardized rates was significantly high. Among the surviving patients, less than one-half recovered on average, whereas one-third improved, and 20% remained chronically ill. The normalization of the core symptoms, involving weight, menstruation, and eating behaviors, was slightly better when each symptom was analyzed in isolation. The presence of other psychiatric disorders at follow-up was very common. Longer duration of follow-up and, less strongly, younger age at onset of illness were associated with better outcome. There was no convincing evidence that the outcome of anorexia nervosa improved over the second half of the last century. Several prognostic features were isolated, but there is conflicting evidence. Most clearly, vomiting, bulimia, and purgative abuse, chronicity of illness, and obsessive-compulsive personality symptoms are unfavorable prognostic features. Anorexia nervosa did not lose its relatively poor prognosis in the 20th century. Advances in etiology and treatment may improve the course of patients with anorexia nervosa in the future.

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Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial.

K Sutandar-Pinnock, Paul Staab, Nir Lipsman … (2013)

Anorexia nervosa is characterised by a chronic course that is refractory to treatment in many patients and has one of the highest mortality rates of any psychiatric disorder. Deep brain stimulation (DBS) has been applied to circuit-based neuropsychiatric diseases, such as Parkinson's disease and major depression, with promising results. We aimed to assess the safety of DBS to modulate the activity of limbic circuits and to examine how this might affect the clinical features of anorexia nervosa. We did a phase 1, prospective trial of subcallosal cingulate DBS in six patients with chronic, severe, and treatment-refractory anorexia nervosa. Eligible patients were aged 20-60 years, had been diagnosed with restricting or binge-purging anorexia nervosa, and showed evidence of chronicity or treatment resistance. Patients underwent medical optimisation preoperatively and had baseline body-mass index (BMI), psychometric, and neuroimaging investigations, followed by implantation of electrodes and pulse generators for continuous delivery of electrical stimulation. Patients were followed up for 9 months after DBS activation, and the primary outcome of adverse events associated with surgery or stimulation was monitored at every follow-up visit. Repeat psychometric assessments, BMI measurements, and neuroimaging investigations were also done at various intervals. This trial is registered with ClinicalTrials.gov, number NCT01476540. DBS was associated with several adverse events, only one of which (seizure during programming, roughly 2 weeks after surgery) was serious. Other related adverse events were panic attack during surgery, nausea, air embolus, and pain. After 9 months, three of the six patients had achieved and maintained a BMI greater than their historical baselines. DBS was associated with improvements in mood, anxiety, affective regulation, and anorexia nervosa-related obsessions and compulsions in four patients and with improvements in quality of life in three patients after 6 months of stimulation. These clinical benefits were accompanied by changes in cerebral glucose metabolism (seen in a comparison of composite PET scans at baseline and 6 months) that were consistent with a reversal of the abnormalities seen in the anterior cingulate, insula, and parietal lobe in the disorder. Subcallosal cingulate DBS seems to be generally safe in this sample of patients with chronic and treatment-refractory anorexia nervosa. Klarman Family Foundation Grants Program in Eating Disorders Research and Canadian Institutes of Health Research. Copyright © 2013 Elsevier Ltd. All rights reserved.

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Journal

Journal ID (nlm-ta): J Clin Med

Journal ID (iso-abbrev): J Clin Med

Journal ID (publisher-id): jcm

Title: Journal of Clinical Medicine

Publisher: MDPI

ISSN (Electronic): 2077-0383

Publication date (Electronic): 22 June 2020

Publication date Collection: June 2020

Volume: 9

Issue: 6

Electronic Location Identifier: 1946

Affiliations

[1 ]Department of Neurosurgery, Hospital del Mar, 08003 Barcelona, Spain; gloriavillabamartinez@ 123456gmail.com (G.V.M.); idelgadom@ 123456parcdesalutmar.cat (I.D.-M.); gconesa@ 123456parcdesalutmar.cat (G.C.)

[2 ]Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193 Barcelona, Spain; vperezsola@ 123456parcdesalutmar.cat

[3 ]Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain; ajusticia@ 123456imim.es

[4 ]Institut de Neuropsiquiatria i Adiccions (INAD), Hospital del Mar, 08003 Barcelona, Spain; psalgado@ 123456parcdesalutmar.cat (P.S.); jgines@ 123456parcdesalutmar.cat (J.M.G.); rguardiola@ 123456parcdesalutmar.cat (R.G.); ccedron@ 123456parcdesalutmar.cat (C.C.); mpolo@ 123456parcdesalutmar.cat (M.P.)

[5 ]Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), 28029 Madrid, Spain

[6 ]Department of Radiology, Hospital del Mar, 08003 Barcelona, Spain; santiago.medrano@ 123456upf.edu

[7 ]Department of Neurology, Hospital del Mar, 08003 Barcelona, Spain; rmanero@ 123456parcdesalutmar.cat

[8 ]Department of Surgery, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, 08193 Barcelona, Spain

[9 ]ITA, Mental Health Specialists, 08036 Barcelona, Spain; gfaus@ 123456ita.com (G.F.); agrau@ 123456ita.com (A.G.)

Author notes

[* ]Correspondence: melices@ 123456imim.es ; Tel.: +34-933160

Author information

Azucena Justicia https://orcid.org/0000-0002-5950-9528

Víctor Pérez https://orcid.org/0000-0002-5825-2337

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Publisher ID: jcm-09-01946

DOI: 10.3390/jcm9061946

PMC ID: 7357090

PubMed ID: 32580399

SO-VID: afbd0b22-5070-4916-a256-5595e6d73608

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Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

A Randomized Trial of Deep Brain Stimulation to the Subcallosal Cingulate and Nucleus Accumbens in Patients with Treatment-Refractory, Chronic, and Severe Anorexia Nervosa: Initial Results at 6 Months of Follow Up

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Most cited references 34

Deep brain stimulation: current challenges and future directions

The outcome of anorexia nervosa in the 20th century.

Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial.

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