Anorexia NervosaNCT03144986
Insula-coil Deep TMS for Treatment Resistant Anorexia Nervosa
A study testing Deep Insula-coil rTMS in people with Anorexia Nervosa, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Deep Insula-coil rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Safety Screening for rTMS (see exclusion criteria)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Determine the Safety and Efficacy of H-Coil Deep Transmagnetic Stimulation in Treatment Resistant Anorexia Nervosa
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).
Read the detailed description
Anorexia Nervosa (AN) is a complex disorder that is characterized by disordered eating behaviors and specific psychopathology. It is frequently unremitting, and is associated with significant morbidity and mortality. There are no effective evidenced based treatments for adult individuals who suffer from this disease, and innovative treatment strategies are constantly being sought. One potential novel treatment approach is brain stimulation, specifically repetitive transcranial magnetic stimulation (rTMS) which has been used to treat various neurobehavioural disorders, including anxiety and depression. There are a number of deep brain regions implicated in the etiology of AN, including the insula. The insula has been identified as an important region in AN pathophysiology. The insula has a role in gustatory modulation and feeding behavior, as well as the processing of interoceptive stimuli and self awareness. In a metanalysis of published fMRI studies in patients with anorexia nervosa, we found hyperactivity in the region of the insula. However activation of such deeper regions with TMS has to date been unachievable as TMS technology has not yet had the capacity to target such deep brain structures. The Brainsway H-coil reaches deep subcortical structures such as the insula.
This pilot study will investigate the efficacy and safety of the Brainsway H-coil deep brain rTMS in the treatment of patients with treatment resistant anorexia nervosa (TrAN). The general objective of this study is to investigate the neurological pathways implicated in AN using Hcoil deep rTMS. The specific goal is to test the safety and tolerability of repeated H-coil TMS as a potential treatment for TrAN. Also, if the safety and tolerability of deep H-coil rTMS stimulation is demonstrated in this study, this modality may be useful as a potential treatment strategy for individuals with AN. If both efficacy and safety are demonstrated, then a properly designed randomized controlled trial with deep H-coil rTMS compared to sham rTMS treatment will be implemented to investigate the possible therapeutic effects of H-Coil deep rTMS stimulation.
- Conditions
- Anorexia Nervosa
- Being tested
- Deep Insula-coil rTMS
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Insula-coil rTMSDevice
Also called deep H-coil rTMS; deep insula rTMS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Deep Insula-coil rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizures
absence of seizures as observed by clinical team and reported by participants
Measured: bi-weekly through for 12 weeks
Secondary outcomes (4)
Decrease in binge eating and purging in B/P group
as reported by participants
Measured: b-weekly for 12 weeks
Increase in calorie intake
as measured by self-report thorough the use of food journal
Measured: bi-weekly for 12 weeks
Decrease in depressive and anxiety
as measured by HAMD, MADRS, BDI, and BDS
Measured: bi-weekly for 12 weeks
Decrease in AN-related obsessions and compulsions
as measured by YBOCS-ED
Measured: bi-weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startSep 2012
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway
- Responsible party
- Principal investigator, Allan Kaplan, Centre for Addiction and Mental Health
- Investigators
- Daniel Blumberger, MD, FRCP(C), Study chair, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144986
- Sponsor's protocol ID
- 174/2010
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Safety and Efficacy of H-Coil Deep Transmagnetic Stimulation in Treatment Resistant Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03144986
- Acronym / sponsor ID
- 174/2010
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Brainsway
- Study start
- Sep 2012 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Anorexia Nervosa (AN) is a complex disorder that is characterized by disordered eating behaviors and specific psychopathology. It is frequently unremitting, and is associated with significant morbidity and mortality. There are no effective evidenced based treatments for adult individuals who suffer from this disease, and innovative treatment strategies are constantly being sought. One potential novel treatment approach is brain stimulation, specifically repetitive transcranial magnetic stimulation (rTMS) which has been used to treat various neurobehavioural disorders, including anxiety and depression. There are a number of deep brain regions implicated in the etiology of AN, including the insula. The insula has been identified as an important region in AN pathophysiology. The insula has a role in gustatory modulation and feeding behavior, as well as the processing of interoceptive stimuli and self awareness. In a metanalysis of published fMRI studies in patients with anorexia nervosa, we found hyperactivity in the region of the insula. However activation of such deeper regions with TMS has to date been unachievable as TMS technology has not yet had the capacity to target such deep brain structures. The Brainsway H-coil reaches deep subcortical structures such as the insula.
This pilot study will investigate the efficacy and safety of the Brainsway H-coil deep brain rTMS in the treatment of patients with treatment resistant anorexia nervosa (TrAN). The general objective of this study is to investigate the neurological pathways implicated in AN using Hcoil deep rTMS. The specific goal is to test the safety and tolerability of repeated H-coil TMS as a potential treatment for TrAN. Also, if the safety and tolerability of deep H-coil rTMS stimulation is demonstrated in this study, this modality may be useful as a potential treatment strategy for individuals with AN. If both efficacy and safety are demonstrated, then a properly designed randomized controlled trial with deep H-coil rTMS compared to sham rTMS treatment will be implemented to investigate the possible therapeutic effects of H-Coil deep rTMS stimulation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Deep insula-coil rTMS | Experimental | Device: Deep Insula-coil rTMSActive 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Insula-coil rTMSAlso: deep H-coil rTMS; deep insula rTMSBefore 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. | Device | Deep insula-coil rTMS |
Primary outcome
Seizures
Time frame: bi-weekly through for 12 weeks
absence of seizures as observed by clinical team and reported by participants
4 secondary outcomes
Decrease in binge eating and purging in B/P group
Time frame: b-weekly for 12 weeks
Increase in calorie intake
Time frame: bi-weekly for 12 weeks
Decrease in depressive and anxiety
Time frame: bi-weekly for 12 weeks
Decrease in AN-related obsessions and compulsions
Time frame: bi-weekly for 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Blumberger, MD, FRCP(C) study chair
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Insula-coil rTMS in people with Anorexia Nervosa, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizures (time frame: bi-weekly through for 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.