Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-04-20 @ 7:54 AM
Study NCT ID:
NCT02702167
Status:
TERMINATED
Last Update Posted:
2021-09-29
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'COVID-19 pandemic restrictions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resting-state functional MRI', 'timeFrame': '1 week pre- and 1 week post-intervention', 'description': '10 min resting-state functional MRI acquisition at 3T'}], 'primaryOutcomes': [{'measure': 'Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE)', 'timeFrame': 'Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Eating Disorder Inventory-3', 'timeFrame': 'Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment'}, {'measure': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': 'Baseline, after each week of treatment, and 1, 4, 12, and 24 weeks post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain stimulation', 'rTMS'], 'conditions': ['Bulimia Nervosa', 'Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Patient):\n\n* Voluntary and Competent to Consent\n* MINI confirmed Diagnosis of Bulimia Nervosa OR Anorexia Nervosa, Binge/Purge subtype\n* Outpatient\n* Between the ages of 18-65\n* Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening\n* Must adhere to research schedule.\n* Pass the TMS Safety Screening Questionnaire.\n* Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.\n\nExclusion Criteria (Patient):\n\n* Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump\n* Have active suicidal intent\n* Are pregnant\n* Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms\n* 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\n* Have received rTMS for any previous indication due to the potential compromise of subject blinding.'}, 'identificationModule': {'nctId': 'NCT02702167', 'briefTitle': 'High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Bulimia and Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '16-6252-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-frequency rTMS', 'description': '10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks', 'interventionNames': ['Device: High-frequency rTMS']}, {'type': 'EXPERIMENTAL', 'label': 'Low-frequency rTMS', 'description': '1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks', 'interventionNames': ['Device: Low-frequency rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham rTMS', 'description': 'Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 6 weeks', 'interventionNames': ['Device: Sham rTMS']}], 'interventions': [{'name': 'High-frequency rTMS', 'type': 'DEVICE', 'otherNames': ['Magventure Cool DB80 Active/Placebo Coil'], 'description': '10 Hz active stimulation, once daily', 'armGroupLabels': ['High-frequency rTMS']}, {'name': 'Low-frequency rTMS', 'type': 'DEVICE', 'otherNames': ['Magventure Cool DB80 Active/Placebo Coil'], 'description': '1 Hz active stimulation, once daily', 'armGroupLabels': ['Low-frequency rTMS']}, {'name': 'Sham rTMS', 'type': 'DEVICE', 'otherNames': ['Magventure Cool DB80 Active/Placebo Coil'], 'description': 'Sham stimulation, once daily', 'armGroupLabels': ['Sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jonathan Downar, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'Blake Woodside, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist', 'investigatorFullName': 'Blake Woodside', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}