Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa

NCT03144986 | Completed

• 1 other identifier: 174/2010
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE: Anorexia Nervosa (AN) is a complex disorder of unknown etiology that is characterized by disordered eating behaviors and specific psychopathology. In the course of anorexia around 50% will recover in the first 10 years, 25% will continue to experience symptoms but will be able to function, and 25% will go to develop chronic course, and by definition become severe treatment resistant(Tr). There is little if anything to offer to this population where the range of treatment options is limited to weight restoration interventions. Transcranial magnetic stimulation (rTMS) is a non-invasive intervention, which presents a particular interest in people with severe TrAN, specifically because of its ability to target deeper areas of the brain, such as insula, which has been argued to be a possible trait marker for AN. METHODS: This pilot study will test the efficacy and safety of deep-rTMS delivered with the H-coil in subjects with long standing treatment resistant severe anorexia nervosa (TrAN).

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

• Seizures

  absence of seizures as observed by clinical team and reported by participants

  bi-weekly through for 12 weeks

Secondary Outcomes (4)

• Decrease in binge eating and purging in B/P group

  b-weekly for 12 weeks

• Increase in calorie intake

  bi-weekly for 12 weeks

• Decrease in depressive and anxiety

  bi-weekly for 12 weeks

• Decrease in AN-related obsessions and compulsions

  bi-weekly for 12 weeks

Study Arms (1)

Deep insula-coil rTMS

EXPERIMENTAL

Active treatment phase consists of deep rTMS (18 Hz, 2 sec on, 20 sec off, over approximately 30 min) 5 times per week, for 6 weeks, for a total of 30 sessions as a part of an active treatment phase. Maintaince treatment phase includes two sessions of rTMS (18 Hz, 2 sec on, 20 sec off, over approximately half an hour) weekly for the period of 6 weeks.

Device: Deep Insula-coil rTMS

Interventions

Deep Insula-coil rTMS DEVICE

Before administering TMS participants will undergo cue stimuli provocation, consisting of 32 professional color images of high calorie, sweet and savory food. This will follow with TMS. All subjects will receive prefrontal deep TMS (18 Hz, 2 sec on, 20 sec off, over approximately 30 min) 5 times per week, for 6 weeks, for a total of 30 sessions as a part of an active treatment phase. Maintenance treatment phase will include two sessions of rTMS (18 Hz, 2 sec on, 20 sec off, over approximately half an hour) weekly for the period of 6 weeks.

Also known as: deep H-coil rTMS; deep insula rTMS

Deep insula-coil rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with AN according to DSM-IV criteria: For DSM-IV, amenorrhea will not be strictly applied, as these subjects have been shown to be clinically indistinguishable from those with full criteria AN.
• Body Mass Index (BMI) \> 14.0 kg/m2 and \< 18.5 kg/m2
• Ages \> 18 years, \< 55 years
• Patient have had \> 2 failed attempts at intensive nutritional rehabilitation, either in an inpatient or day hospital setting, and have been ill with AN for more than 5 years
• Medically stable
• Competent to provide Informed Consent
• Speak and understand English

You may not qualify if:

• Any medical or psychiatric problem requiring urgent medical or psychiatric attention (e.g. acute suicidality),
• significant metabolic disturbance upon psychiatrist presentation (e.g., K+ \< 2.5 mEq/L),
• patients with significant co-morbid illnesses that are not likely to benefit from proposed treatments or that need specialized treatments for non-eating disorder symptoms. (Note that once a participant is already in the study, participant may remain if medical problems develop but are corrected in a timely fashion. Please see criteria for study withdrawal for details)
• Pregnancy
• QTc \> 480 msec at baseline or increase in QTc of \> 35 msec since baseline ECG
• Significant systemic or metabolic illness; i.e.,diabetes mellitus( fasting blood sugar \> 120 mg/dL or non-fasting \> 140 md/dL) or hyperlipidemia ( cholesterol, triglycerides \> 1.5 x upper limit of normal)
• Current diagnosis of substance abuse or dependence in past 6 months
• Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I)
• Significant neurological disorder, including past history of documented seizure, familial or personal history of epilepsy, ECT within past 3months prior to screening, history of rTMS in the past 3months
• Presence of any intracranial medical device, or any metal objects which may be present in the body
• Taking mood stabilizers or anticonvulsants. Subjects will be allowed in the study if they are taking a low stable dose of antidepressant or antipsychotic medication for a period of \> 4 weeks at an unchanged dose.
• Participation in a psychotherapeutic intervention instituted within 3 months of the beginning of the trial. Subjects in psychotherapy at a stable frequency for at least the last 3 months prior to entering the study will be allowed to participate

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Brainsway: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Daniel Blumberger, MD, FRCP(C)

  Centre for Addiction and Mental Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A pilot study to investigate the efficacy and safety of deep-rTMS delivered with the H-coil able to reach insula in subjects with long standing treatment resistant severe anorexia nervosa (TrAN)

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 9, 2017
• Study Start: September 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)