ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618002047279

Ethics application status

Approved

Date submitted

13/12/2018

Date registered

21/12/2018

Date last updated

2/12/2019

Date data sharing statement initially provided

21/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Deep Brain Stimulation (DBS) of the Nucleus Accumbens for Treatment Resistant Severe and Enduring Anorexia Nervosa: A Phase 1 Open Trial

Scientific title

Efficacy and safety of Deep Brain Stimulation (DBS) of the Nucleus Accumbens for Treatment Resistant Severe and Enduring Anorexia Nervosa: A Phase 1 Open Trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1219-9348

Trial acronym

DBS-SEAN

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anorexia Nervosa

Condition category

Condition code

Surgery

Surgical techniques

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aims of this study are to determine the efficacy of Deep Brain Stimulation in treatment-resistant severe and enduring anorexia nervosa.

Surgical Procedure:
Participants will have the Vercise Gevia Deep Brain Stimulation System surgically implanted by a neurosurgeon according to standard stereotactic procedures. All patients will undergo bilateral implantation. Device implantation is permanent and participants will have the option to continue with the therapy post-trial or have the device switched or and/or removed.

The device provides electrical stimulation to the Nucleus Accumbens (NAcc). Stimulation is provided by controlled delivery of current from a battery in an implantable neurostimulator (INS) connected by extension leads from the body through the neck to electrodes surgically implanted in the brain.

Stimulation programs are controlled by the neurologist via the clinical programmer. The total procedure is approximately 3.5 hours in duration. As in the standard procedure patients are woken intra-operatively and will also complete an image recognition task.

Randomisation to ON or OFF stimulation in the blinded phase will occur at this time point in a 50:50 ratio. Randomisation will take place externally and allocation will be concealed from participants and investigators, excepting those responsible for DBS programming.

Post-operatively participants will undergo a CT scan to verify electrode positioning.

Stimulation / Programming:
Participants will visit the centre for programming of the device by the neuropsychiatrist. Programming sessions will last approximately 30 minutes and are initially weekly, becoming less frequent when parameters are stable. Initial stimulation will commence bilateral stimulation, monopolar configuration. The clinician will initially review the response at weekly-fortnightly intervals. During initial phase aim is to increase stimulation amplitude by 0.5mA to 1mA per visit until a target amplitude of 4MA is reached.

If there is an insufficient response after initial phase amplitude will be increased in 0.2mA to 0.5mA increments.

Clinical Assessments:
Assessment sessions are scheduled every 3 months. The following will be administered:
* Eating Disorder Examination Questionnaire (EDE-Q 6.0)
* Depression Anxiety and Stress Scale (DASS)
* Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
* Montreal Cognitive Assessment (MoCA)
* Clinical Impairment Assessment Questionnaire (CIA)
* Body Mass Index (BMI)

Patients will attend a clinic at the Royal Brisbane & Women's Hospital. The clinic will take approximately 1 hour and will be with the trial's psychologist.

Image Recognition Task:
Every 3 months participants will also undergo an EEG with a researcher at the Queensland Brain Institute. Under the EEG condition participants will complete an image presentation task. This session will take approximately 1 hour.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

The study will follow a randomised, placebo controlled, double blind, staggered onset design. All participants will have a deep brain stimulation device inserted and this will not be turned on for one month. At four weeks post surgery, the participants randomly selected to the "on" stimulation group will have their devices switched on. At four months post surgery, participants selected to the "off" stimulation group will have their devices switched on.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is any serious adverse events, or adverse events leading to permanent discontinuation, related to the implantation of or activation of the deep brain stimulation device.

Conditions present at screening and do not deteriorate will not be considered adverse events.

Hospitalisation due to progression of disease will not be considered a serious adverse event for the purposes of this study.

At every study visit patients will be asked how they have been since their last visit in order to elicit any medically related changes in their well-being. Hospitalisations, new medication or changed concomitant medication regimens. In addition, adverse events will be documented from physical examination findings, clinically significant lab results or other documents related to patient safety.

The following are possible known adverse events: depression, hypermania, mixed bipolar, cardiac air emblous, postopeartive fever, postopeartive infection, headache.

Timepoint [1]

Adverse events will be recorded from the time the patient signs the informed consent until the final study visit 18 months post-surgery.

Secondary outcome [1]

Body Mass Index (BMI)

The proportion of patients attaining a healthy BMI range of equal to or greater than 18.5.

A measure of relative size based on the height and weight of the individual, calculated as the weight in kilograms divided by the height in metres squared (i.e. kg/m2). Diagnostic and Statistical Manual 5 uses BMI, as a measure of severity of AN. BMI is to be collected preoperatively, whilst baseline BMIs are to be calculated based on patient interviews, weight diaries and medical records.

Timepoint [1]