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Deep Brain Stimulation for the Treatment of Refractory Anorexia Nervosa
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Anorexia nervosa is a chronic, and debilitating psychiatric disorder associated with the highest mortality rate of any psychiatric condition. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress have been made in altering the natural history of the condition or its outcomes. It has further become increasingly accepted that the thoughts and behaviors at the root of AN derive from dysfunctional neuroanatomic circuits, whose activity and deviations can be detected with sophisticated neuroimaging techniques. Much progress has also been made in mapping the psychology of the illness to underlying neuroanatomic and neurophysiologic processes that drive and maintain these behaviors, even in the face of severe starvation and impending death. Dysfunctional reward processing, compulsive hyperactivity, chronic anxiety and depression, all suggest that AN shares much in common with other conditions, such as OCD, for which surgical therapy has been tried, and met with success.
Deep Brain Stimulation is a neurosurgical tool that has been widely used for over twenty years. Most of the experience with DBS comes from the movement disorder literature where significant success has been had with the management of disabling Parkinson's disease (PD) and dystonia. The most experience so far has been in Parkinson's disease where well over 50,000 patients globally have received the operation. DBS is believed to work by using small amounts of electricity to disrupt the activity of brain structures that produce troublesome symptoms. DBS has also been used in psychiatric patients, both as part of treatment and research, in cases of Obsessive-Compulsive Disorder (OCD), and research, in cases of Depression. Current research suggests that there are similarities between Anorexia Nervosa and conditions such as OCD and depression. Given that DBS has shown promise in the treatment of those conditions, this trial was designed to see if it could be an effective therapy for Anorexia Nervosa as well.
This study would be the first exploration of a surgical therapy for refractory AN. The rationale stems from clear and robust evidence pointing at a dysfunctional cortical-subcortical loop driving abnormal behavior, with several important nodes in the loop being particularly important, and recurring, players. The subgenual cingulate plays a role in affective decision making, reward processing, as well as subsequent anxiety and dysphoric mood.
There are currently no brain based, targeted therapies for AN. The scientific significance of this study will be:
i) The first clinical trial exploring deep brain stimulation in an eating disorder population
ii) The first demonstration of the influence of deep brain stimulation on dysfunctional reward processing with co-morbid anxiety/dysphoria
iii) The first 'brain-based' treatment for any eating disorder
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5T2S8
- Toronto Western Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Female or Male patients between age 20-60
- Diagnosis of Anorexia Nervosa, restricting or binge-purging subtype as defined by the Diagnostic and Statistical Manual (DSM-IVR)
Chronicity and/or Treatment Resistance as demonstrated by some or all of:
- A pattern of three year's duration of relentless unresponsiveness to repeated voluntary hospitalizations, characterized by failure to complete treatment of immediate weight relapse following treatment;
- pattern of increasing medical instability accompanied by refusal to participate in/lack of responsiveness to intensive expert treatment and increasing medical acuity, lasting at least two years and involving at least two episodes of involuntary feeding;
- A pattern of chronic stable AN lasting at least 10 years
- Able to comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria:
- Any past or current evidence of psychosis
- Active neurologic disease such as epilepsy
- Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- Any contraindication to Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
- Likely to relocate or move during the study's one year duration
- BMI less than 13
- Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of AN or not, that will result in significant risk from a surgical procedure.
- Pregnancy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Deep Brain Stimulation
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Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Eating Disorder Related Preoccupations and Rituals
Tijdsspanne: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
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Eating Disorder Related Preoccupations and Rituals scores
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Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Depression
Tijdsspanne: Change from baseline in depression scores at 3 months, 6 months and 12 months
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Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI)
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Change from baseline in depression scores at 3 months, 6 months and 12 months
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Anxiety
Tijdsspanne: Change from baseline in anxiety scores at 3 months, 6 months and 12 months
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Beck Anxiety Inventory (BAI)
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Change from baseline in anxiety scores at 3 months, 6 months and 12 months
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Quality of Life questionnaire score through change from baseline compared to post-implant visit
Tijdsspanne: Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months
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Health Survey Short Form (SF36), Quality of Life Scale
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Change from baseline in Quality of Life scores at 3 months, 6 months and 12 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Andres M Lozano, MD, PhD, University Health Network, Toronto
- Hoofdonderzoeker: Blake Woodside, MD, Toronto General Hospital
Publicaties en nuttige links
Algemene publicaties
- Lipsman N, Lam E, Volpini M, Sutandar K, Twose R, Giacobbe P, Sodums DJ, Smith GS, Woodside DB, Lozano AM. Deep brain stimulation of the subcallosal cingulate for treatment-refractory anorexia nervosa: 1 year follow-up of an open-label trial. Lancet Psychiatry. 2017 Apr;4(4):285-294. doi: 10.1016/S2215-0366(17)30076-7. Epub 2017 Feb 24.
- Lipsman N, Woodside DB, Giacobbe P, Hamani C, Carter JC, Norwood SJ, Sutandar K, Staab R, Elias G, Lyman CH, Smith GS, Lozano AM. Subcallosal cingulate deep brain stimulation for treatment-refractory anorexia nervosa: a phase 1 pilot trial. Lancet. 2013 Apr 20;381(9875):1361-1370. doi: 10.1016/S0140-6736(12)62188-6. Epub 2013 Mar 7.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10-0991-A
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Anorexia nervosa
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Rosemary Claire RodenChildren's Miracle NetworkAanmelden op uitnodigingBoulimia nervosa | Impulsief gedrag | Purgeren (eetstoornissen) | Eet stoornissen | Eetstoornissen in de adolescentie | Anorexia nervosa/boulimia | Anorexia in de adolescentie | Anorexia Nervosa, Atypisch | Anorexia Nervosa, type eetbuien/purgerenVerenigde Staten
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Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3WervingAnorexia nervosa | Anorexia Nervosa in Remissie | Anorexia Nervosa beperkend typeSpanje
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Duke UniversityVoltooidAdolescenten met anorexia nervosa | Onderdrempel Anorexia NervosaVerenigde Staten
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University of California, San DiegoWervingAnorexia nervosa | Boulimia nervosa | Atypische anorexia nervosa | Atypische boulimia nervosaVerenigde Staten
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Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH); University of California, San FranciscoVoltooidAnorexia nervosa | Anorexia | Eetstoornis | Eetstoornissen in de adolescentie | Anorexia in de adolescentie | Anorexia Nervosa, Atypisch | Anorexia Nervosa beperkend type | Anorexia bij kinderenVerenigde Staten
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Linnaeus UniversityGöteborg University; Linkoeping UniversityWervingBoulimia nervosa | Grote Depressie | Anorexia nervosa/boulimiaZweden
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Umeå UniversityActief, niet wervendAnorexia nervosa | Anorexia in de adolescentie | Anorexia Nervosa, AtypischZweden
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Yeshiva UniversityYale UniversityWervingAnorexia nervosa | Boulimia nervosa | Anorexia Nervosa, Atypisch | Boulimia; AtypischVerenigde Staten
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... en andere medewerkersWervingAnorexia nervosa | Boulimia nervosa | Atypische anorexia nervosa (andere gespecificeerde eetstoornis) | Atypische boulimia nervosa (andere gespecificeerde eetstoornis)Nederland
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Denver Health and Hospital AuthorityAanmelden op uitnodigingVermijdende restrictieve voedselinnamestoornis | Anorexia Nervosa, type eetbuien/purgeren | ARFID | Anorexia Nervosa beperkend typeVerenigde Staten
Klinische onderzoeken op Deep Brain Stimulation
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Medical College of WisconsinIngetrokken
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Boston Scientific CorporationWervingZiekte van ParkinsonDuitsland
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Johns Hopkins UniversityWervingTourette syndroomVerenigde Staten
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Abbott Medical DevicesVoltooidDepressieve stoornis, majoorIsraël, Frankrijk, Verenigd Koninkrijk
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Boston Scientific CorporationVoltooidZiekte van ParkinsonFrankrijk, Nederland, Duitsland
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Boston Scientific CorporationVoltooidZiekte van ParkinsonVerenigde Staten
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Paul HoltzheimerActief, niet wervendBehandelingsresistente depressie | Depressieve stoornis, therapieresistent | Depressie, bipolairVerenigde Staten
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Paul HoltzheimerVoltooidBehandelingsresistente depressie | Depressieve stoornis, therapieresistent | Depressie, bipolairVerenigde Staten
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Butler HospitalNational Institute of Mental Health (NIMH)Actief, niet wervendObsessief-compulsieve stoornisVerenigde Staten
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Centre Hospitalier St AnneWerving