Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation
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| ClinicalTrials.gov Identifier: NCT06138782 |
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Recruitment Status :
Recruiting
First Posted : November 18, 2023
Last Update Posted : November 28, 2023
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
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Brief Summary:
Transcranial Magnetic Stimulation (TMS) is approved by the Food and Drug Administration (FDA) for the treatment of refractory Major Depressive Disorder (MDD) and obsessive-compulsive disorder (OCD). Anorexia nervosa (AN) is characterized by restrictive eating leading to low weight and associated complications. There is an emerging understanding that the symptoms of OCD and AN overlap as AN can be characterized by obsessive thought patterns around food and compulsive restricting and weight loss behaviors. Both conditions are characterized by a propensity toward cognitive inflexibility and the conditions may share neural substrates that maintain maladaptive habitual behaviors and cognitive rigidity. An evidence-based repetitive transcranial magnetic stimulation (rTMS) target for OCD is the orbitofrontal cortex (OFC). The investigators intend to determine if the OFC is also a potential rTMS target for AN and to determine if there is a characteristic pattern of functional network reorganization as characterized by functional magnetic resonance imaging (fMRI) in TMS responders.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anorexia Nervosa | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) | Not Applicable |
To determine if accelerated theta burst rTMS can treat symptoms of AN and normalize abnormal network connectivity, the investigators will enroll 20 patients with AN (aged 18-45) to receive five treatments of inhibitory continuous theta burst rTMS to the right orbitofrontal cortex (R OFC) lasting three minutes delivered every hour over the course of 10 days (2 weeks) for a total of 50 treatments, with follow-up immediately post-treatment, and at 1 month. Clinical symptom change will be determined with weight gain from percent expected body weight (%EBW) and clinical interview with the Eating Disorders Examination (EDE) as well as validated self-report. For Hypothesis 1: At 1-month post-rTMS, the investigators expect increased %EBW, and meaningful reductions in AN compulsive symptoms per the EDE. For Hypothesis 2: The investigators intend to identify changes in the default mode network comparing before and after TMS that are associated with an improvement in AN compulsive symptoms.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation |
| Actual Study Start Date : | October 16, 2023 |
| Estimated Primary Completion Date : | September 2025 |
| Estimated Study Completion Date : | September 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TMS (Aim 2)
Our protocol consists of five treatments of inhibitory continuous TBS (cTBS) to the R OFC lasting three minutes delivered every hour over the course of 10 days (2 weeks) for a total of 50 treatments.
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Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Our protocol consists of five treatments of inhibitory continuous TBS (cTBS) to the R OFC lasting three minutes delivered every hour over the course of 10 days (2 weeks) for a total of 50 treatments. |
Primary Outcome Measures :
- Eating Disorders Examination - Questionnaire (EDE-Q) [ Time Frame: Baseline; day 1, 5, & 10 of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-report questionnaire designed to assess the range, frequency and severity of behaviours associated with a diagnosis of an eating disorder. It is categorised into 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and an overall global score, with a higher score indicating more problematic eating difficulties.
Secondary Outcome Measures :
- Yale Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Y-BOCS is a 10-item ordinal scale (0-4) that rates the severity separately for both obsessions and compulsions of OCD according to the time occupied, degree of interference, subjective distress, internal resistance, and degree of control. Higher scores indicate worse outcome.
- Compulsive Exercise Test (CET) [ Time Frame: Baseline; day 1, 5, & 10 of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The CET is a 24-item self-report measure designed to assess the core features of excessive exercise in the eating disorders. Higher scores indicate worse outcome.
- State Trait Anxiety Index (STAI) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Higher scores indicate worse outcome.
- Ecological Momentary Assessment (EMA) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]Ecological momentary assessments (EMAs) study people's thoughts and behavior in their daily lives by repeatedly collecting data in an individual's normal environment, at or close to the time that the individual carries out that behavior. Higher scores indicate worse outcome.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Montgomery-Åsberg Depression Rating Scale (MADRS) is a diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher scores indicate worse outcome.
- Hamilton Self-Rating Scale for Depression (HAM-D) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The HAM-D is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Higher scores indicate worse outcome.
- Intolerance of Uncertainty Scale - short form (IUS-12) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Intolerance of Uncertainty Scale (IUS) includes items relating to the idea that uncertainty is unacceptable, reflects badly on a person, and leads to frustration, stress, and the inability to take action. Higher scores indicate worse outcome.
- Repetitive Thinking Questionnaire-10 (RTQ-10) [ Time Frame: Baseline; all 10 days of TMS; every follow-up (weeks 1, 2, & 3 after final TMS treatment; every month for a year). ]The Repetitive Thinking Questionnaire (RTQ) was developed by combining items from commonly used measures of worry, rumination, and post-event processing, and then modifying the items to remove diagnosis-specific content. It is used to measure repetitive negative thinking. Higher scores indicate worse outcome.
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| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- outpatients
- ages 18 - 45 for Aim 2
- meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for AN
- stable on chronic psychotropic medications for 4 weeks prior to the study and agreeable to continue throughout the study
- participants may continue to take medications and record daily usage throughout the study
- capacity to provide informed consent
- ability to tolerate clinical study procedures
- successfully complete the screening forms without any contraindications
Exclusion Criteria:
- Psychiatric: schizophrenia, bipolar disorder, prior psychosurgery, prior electroconvulsive therapy (ECT)
- Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis)
- TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk
- Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension)
- Females who are pregnant or nursing
- Inability to complete the research study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06138782
Contacts
| Contact: Andrew M Lee, MD, PhD | 415-476-7000 | AndrewMoses.Lee@ucsf.edu | |
| Contact: Sasha Gorrell, PhD | 415-502-2716 | Sasha.Gorrell@ucsf.edu |
Locations
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94107 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Andrew M Lee, MD, PhD | University of California, San Francisco |
Publications:
Kaye W. Is food restriction in anorexia nervosa caused by reduced reward and/or increased inhibition? Neuropsychopharmacology. 2011;36(Kaye W.) UCSD, Department of Psychiatry, San Diego, United States):S48. doi:10.1038/npp.2011.290
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT06138782 |
| Other Study ID Numbers: |
23-39333 |
| First Posted: | November 18, 2023 Key Record Dates |
| Last Update Posted: | November 28, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by University of California, San Francisco:
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anorexia AN anorexia nervosa |
OCD obsessive obsessive-compulsive disorder |
Additional relevant MeSH terms:
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Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders |