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Neuromodulation
TMS for Anorexia
N/A
Recruiting
Led By Andrew M Lee, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to provide informed consent
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; all 10 days of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).
Awards & highlights
Study Summary
This trial will study if using a type of brain stimulation called TMS can help people with OCD and anorexia.
Who is the study for?
This trial is for outpatients aged 18-45 with Anorexia Nervosa (AN), stable on psychotropic meds for 4 weeks, and able to give informed consent. Excluded are those with schizophrenia, bipolar disorder, severe neurocognitive disorders, seizure disorders, metal in the head or certain implanted devices.Check my eligibility
What is being tested?
The study tests if Repetitive Transcranial Magnetic Stimulation (rTMS) targeting the orbitofrontal cortex can help treat AN by reorganizing brain networks. Participants' responses will be monitored using functional magnetic resonance imaging (fMRI).See study design
What are the potential side effects?
Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), and temporary hearing changes due to the noise during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the details of the clinical trial and can consent to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; all 10 days of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; all 10 days of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Eating Disorders Examination - Questionnaire (EDE-Q)
Secondary outcome measures
Compulsive Exercise Test (CET)
Ecological Momentary Assessment (EMA)
Hamilton Self-Rating Scale for Depression (HAM-D)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TMS (Aim 2)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2019
Completed Phase 2
~780
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment that modulates neural activity by using magnetic fields to stimulate nerve cells in specific brain regions, such as the orbitofrontal cortex (OFC). The OFC is involved in decision-making and reward processing, which are often disrupted in Anorexia Nervosa (AN).
By targeting this area, TMS aims to alleviate obsessive thoughts and compulsive behaviors related to food and body image, potentially improving cognitive flexibility and reducing maladaptive habits. Understanding these mechanisms is crucial for AN patients as it offers a targeted approach to address the underlying neural dysfunctions, providing a potential alternative when traditional therapies are insufficient.
Repetitive transcranial magnetic stimulation in the treatment of eating disorders: A review of safety and efficacy.
Repetitive transcranial magnetic stimulation in the treatment of eating disorders: A review of safety and efficacy.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,523 Previous Clinical Trials
15,242,984 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
532 Patients Enrolled for Anorexia Nervosa
Andrew M Lee, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
15 Total Patients Enrolled
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