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Pilot Study of Deep Brain Stimulation for Severe Anorexia Nervosa

NCT01924598 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-09

No results posted yet for this study

Summary

Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of effective treatments. AN becomes intractable in around 20%, resulting in huge individual and healthcare costs. Exploration of underlying processes and novel treatment strategies is thus crucial. This is a pilot study of a novel translational approach to the investigation and treatment of severe AN. The aims are (1) to explore the safety, acceptability and feasibility of Deep Brain Stimulation (DBS) for AN (2) to map neural mechanisms underpinning aberrant reward and optimise DBS targets. The study will involve 10 consenting adults with full mental capacity, and the nain protocol will last 15 months. . There is then optional annual follow ups for up to 5 years .It incorporates an ethical substudy including assessment of capacity and informed consent. It combines complementary forms of cutting edge neuroimaging including fMRI and MEG (magnetoencephalography). These will be complimentary in helping identify the best strategy for treating severe AN using DBS. Individuals with severe intractable AN will be eligible to take part. The study will be conducted in Oxford, United Kingdom at the John Radcliffe and Warneford Hospitals. The individuals will have preoperative ethical, neuroimaging and psychological assessments, A DBS operation in month 2, DBS switch on in month 3 month postoperatively . DBS will be targeted to the Nucleus accumbens, followed by a 12 month post switch on follow-up period with monthly joint neurosurgical psychiatric and psychological assessments and postoperative MEG scans . The study will further our understanding of food reward processes in general and AN in particular indeed promises to provide important information which may revolutionize future treatments. The proposal builds upon a body of research investigating the role of aberrant reward processes in AN and exploits our complementary research experience in AN using experimental behavioural strategies, fMRI , MEG and DBS to establish a powerful translational research strategy.

Conditions

  • Severe Enduring Anorexia Nervosa

Interventions

DEVICE

DBS to nucleus accumbens/anterior limb of internal capsule

deep brain stimulation followed by 12 month post switch on followup

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Tipu Aziz, MD · University of Oxford

  • Rebecca Park, MD Phd · University of Oxford

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924598 on ClinicalTrials.gov