Bulimia NervosaNCT02702167
High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa
A study testing High-frequency rTMS and Low-frequency rTMS in people with Bulimia Nervosa and Anorexia Nervosa, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bulimia Nervosa, Anorexia Nervosa
- What is being tested?
- High-frequency rTMS and Low-frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 30 Apr 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary and Competent to Consent
- MINI confirmed Diagnosis of Bulimia Nervosa OR Anorexia Nervosa, Binge/Purge subtype
- Outpatient
- Between the ages of 18-65
- Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
- Must adhere to research schedule.
- Pass the TMS Safety Screening Questionnaire.
- Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
Who cannot join
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
- Have active suicidal intent
- Are pregnant
- Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- Have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than the ED
- Have received rTMS for any previous indication due to the potential compromise of subject blinding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dorsomedial Prefrontal Cortex as a Target in Treatment-resistant Bulimia Nervosa and Anorexia Nervosa: Investigating Target Engagement, Dosing, Reliability and Duration of Effect Using rTMS, fMRI, and a Sham Controlled Arm
This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. The trial will include structural and functional MRI, and behavioral measures obtained before, during, and after treatment.
- Conditions
- Bulimia Nervosa, Anorexia Nervosa
- Being tested
- High-frequency rTMS, Low-frequency rTMS, Sham rTMS
- Keywords
- brain stimulation, rTMS
- Medical subject headings
- Bulimia Nervosa, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
10 Hz active stimulation, once daily
Low-frequency rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
1 Hz active stimulation, once daily
Sham rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
Sham stimulation, once daily
| Study group | Role | What they receive |
|---|---|---|
| High-frequency rTMS | Experimental | 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks Receives: Device: High-frequency rTMS |
| Low-frequency rTMS | Experimental | 1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks Receives: Device: Low-frequency rTMS |
| Sham rTMS | Sham comparator | Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.
Measured: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes (2)
Eating Disorder Inventory-3
Measured: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Eating Disorder Examination Questionnaire (EDE-Q)
Measured: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start1 Nov 2017
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: COVID-19 pandemic restrictions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blake Woodside, University Health Network, Toronto
- Investigators
- Jonathan Downar, MD PhD, Principal investigator, University Health Network, TorontoBlake Woodside, MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702167
- Sponsor's protocol ID
- 16-6252-B
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dorsomedial Prefrontal Cortex as a Target in Treatment-resistant Bulimia Nervosa and Anorexia Nervosa: Investigating Target Engagement, Dosing, Reliability and Duration of Effect Using rTMS, fMRI, and a Sham Controlled Arm
- ClinicalTrials.gov ID
- NCT02702167
- Acronym / sponsor ID
- 16-6252-B
- Conditions
- Bulimia Nervosa, Anorexia Nervosa
- Keywords
- brain stimulation, rTMS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic restrictions.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
This trial will compare the efficacy and tolerability of 10 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered once daily over 30 days, in patients with a diagnosis of bulimia or anorexia nervosa binge-purge subtype. The trial will include structural and functional MRI, and behavioral measures obtained before, during, and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency rTMS | Experimental | Device: High-frequency rTMS10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
| Low-frequency rTMS | Experimental | Device: Low-frequency rTMS1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary and Competent to Consent
- MINI confirmed Diagnosis of Bulimia Nervosa OR Anorexia Nervosa, Binge/Purge subtype
- Outpatient
- Between the ages of 18-65
- Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
Key exclusion criteria (6 listed)
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
- Have active suicidal intent
- Are pregnant
- Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- Have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than the ED
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 |
|---|---|---|
| High-frequency rTMSAlso: Magventure Cool DB80 Active/Placebo Coil10 Hz active stimulation, once daily | Device | High-frequency rTMS |
| Low-frequency rTMSAlso: Magventure Cool DB80 Active/Placebo Coil1 Hz active stimulation, once daily | Device | Low-frequency rTMS |
| Sham rTMSAlso: Magventure Cool DB80 Active/Placebo CoilSham stimulation, once daily | Device | Sham rTMS |
Primary outcome
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)
Time frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Outcome measured by a change in weekly binge and purge episodes from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of 0 weekly binges and 0 weekly vomits is categorized as remission.
2 secondary outcomes
Eating Disorder Inventory-3
Time frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment
Results and safety
The study was stopped early (reason given: COVID-19 pandemic restrictions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Downar, MD PhD principal investigator
University Health Network, Toronto
Blake Woodside, MD FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency rTMS and Low-frequency rTMS in people with Bulimia Nervosa and Anorexia Nervosa, run by University Health Network, Toronto 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 6 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: stopped early, as of the sponsor's last update on 29 Sep 2021. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: COVID-19 pandemic restrictions.). Results are not available in the source record.
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?
Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE) (time frame: Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment). 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 Sep 2021.