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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 below

Select...

I understand the details of the clinical trial and can consent to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; day 1, 5, & 10 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; day 1, 5, & 10 of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; day 1, 5, & 10 of tms; every follow-up (weeks 1, 2, & 3 after final tms treatment; every month for a year). for reporting.

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 more

Trial 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,535 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for prospective participants of this trial?

"Affirmative. According to clinicaltrials.gov, this clinical trial is recruiting participants after first being posted on October 16th 2023 and last updated November 15th 2023. Specifically, the study seeks out 20 candidates at one medical facility."

Answered by AI

Does the research project accept participants aged 55 or older?

"The age range for enrolment in this trial is 18 to 45. Additionally, there are 43 clinical trials open to younger patients and 40 available to those over the age of 65."

Answered by AI

What is the upper population limit of this clinical trial?

"Affirmative, the information available on clinicaltrials.gov clearly indicates that this medical experiment is currently enrolling participants. It was initially posted on October 16th 2023 and subsequently updated November 15th 2023. This trial requires enlistment of up to 20 patients from a single site."

Answered by AI

Is there a possibility that I might be accepted into this experiment?

"Individuals who have anorexia nervosa and are between 18-45 years old qualify for this research study, which is planned to enrol roughly 20 participants."

Answered by AI

Recent research and studies

American Journal of PsychiatryJournal

Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-compulsive Disorder: A Prospective Multicenter Randomized Double-blind Placebo-controlled Trial

Carmi, Lior, Aron Tendler, Alexander Bystritsky, Eric Hollander, Daniel M. Blumberger, Jeff Daskalakis, Herbert Ward, et al.. 2019. “Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-compulsive Disorder: A Prospective Multicenter Randomized Double-blind Placebo-controlled Trial”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2019.18101180.

clinicaltrials.govStudy

Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation

2023. "Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138782.

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