rTMS for Anorexia Nervosa

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Must not be taking: Ototoxic medications

Disqualifiers: Substance use disorder, Psychosis, Epilepsy, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests high-frequency repetitive transcranial magnetic stimulation (rTMS) to determine its effects on food choices and brain activity in individuals with anorexia nervosa. rTMS is a non-invasive procedure that uses magnetic fields to stimulate brain nerve cells. The trial includes two groups: one receiving real rTMS and another receiving a sham (fake) version for comparison. Right-handed women who speak English and have been diagnosed with anorexia nervosa while being medically stable may be eligible to participate. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for anorexia nervosa.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking medication that significantly increases the risk for seizures or affects the study's findings.

What prior data suggests that high-frequency repetitive transcranial magnetic stimulation is safe for treating anorexia nervosa?

Research has shown that high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) is generally safe for treating anorexia nervosa. Studies have found that patients usually tolerate it well. Most people experience only minor and temporary side effects, such as mild headaches or discomfort at the treatment site, but these effects typically do not last long.

Overall, HF-rTMS appears to be a promising treatment option with a good safety record for people with anorexia nervosa. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) for anorexia nervosa because it offers a novel approach by targeting specific brain regions linked to the condition. Unlike traditional treatments, which often involve therapy and medications like antidepressants, HF-rTMS directly stimulates the right dorsolateral prefrontal cortex (DLPFC) to potentially improve connectivity with the dorsal striatum. This targeted approach may lead to more effective results. Additionally, HF-rTMS is non-invasive and could provide an alternative for patients who have not responded well to existing treatments. The possibility of a new, brain-focused method gives hope for better outcomes in managing anorexia nervosa.

What evidence suggests that high-frequency repetitive transcranial magnetic stimulation could be effective for anorexia nervosa?

Research has shown that high-frequency repetitive transcranial magnetic stimulation (HF-rTMS), a treatment participants in this trial may receive, can help people with anorexia nervosa. Studies have found that it can improve body mass index (BMI) and key symptoms of the disorder. One study linked HF-rTMS on a specific part of the brain to reduced consumption of fatty food. Overall, 32 studies reported that rTMS can improve mood and symptoms of eating disorders in people with anorexia nervosa. These findings suggest that HF-rTMS could be a promising treatment option for this condition. ^{1 4 5 6 7}

Who Is on the Research Team?

Alexandra F Muratore, PhD

Principal Investigator

New York Sate Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for right-handed women aged 18-30 with a diagnosis of Anorexia Nervosa according to DSM-5, having a BMI of at least 16.0. Participants must be voluntarily admitted to an inpatient eating disorders unit, medically stable, competent to consent, and English-speaking.

Inclusion Criteria

Right-handed

I have been diagnosed with anorexia nervosa.

Body Mass Index (BMI) ≥ 16.0

Exclusion Criteria

I don't have major health issues or take meds that could cause seizures or affect test results.

I have had seizures in the past.

Food restrictions (e.g., allergies) which impact greater than 30% of food choice task's choice options

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) or sham rTMS to the DLPFC

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-frequency repetitive transcranial magnetic stimulation (active rTMS)
• Sham repetitive transcranial magnetic stimulation (sham rTMS)

Trial Overview The study tests the effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) on food choice behavior compared to sham rTMS which mimics the procedure without active treatment.

How Is the Trial Designed?

Group I: High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) Experimental Treatment 1 Intervention

Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: 10 pulses/sec, 4s trains, 120% MT, 3000 pulses/session

Group II: Sham repetitive transcranial magnetic stimulation (sham rTMS) Placebo Group 1 Intervention

Target: Region of right DLPFC with greatest resting-state functional connectivity to dorsal striatum (individualized functional target) Protocol: same as HF-rTMS, with sham coil

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Global Foundation for Eating Disorders

Collaborator

Trials

2

Recruited

80+

National Eating Disorders Association

Collaborator

Trials

6

Recruited

530+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11735571/

Efficacy of transcranial magnetic stimulation in anorexia nervosa TMS represents an effective therapy for patients with AN, leading to improvements in both BMI and core symptoms of AN, with minor and transient side effects.

2. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00420-w

A pilot study exploring the effect of repetitive transcranial ... Repetitive transcranial magnetic stimulation (rTMS) is a novel treatment option for people with severe enduring anorexia nervosa (SE-AN).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9126092/

Use of high-frequency repetitive transcranial magnetic ... Findings suggest that HF-rTMS to the right DLPFC was associated with a reduction of fat avoidance on a food choice task among inpatients with AN.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/erv.70046

rTMS Therapy for Eating Disorders: Scoping Review ... Thirty-two studies were included. Benefits of rTMS on mood or eating disorder symptoms were reported for patients with anorexia nervosa.

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp-rj.2023.180302

Repetitive Transcranial Magnetic Stimulation Strategies in ... Findings indicated that rTMS is safe for patients with anorexia nervosa and well tolerated, but large randomized controlled trials comparing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04409704

Repetitive Transcranial Magnetic Stimulation of the ... Are voluntary and competent to consent to treatment. Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the last 6 months at ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178117319960

Repetitive transcranial magnetic stimulation in the ... In this review, some studies showed relatively positive results with safe outcomes and with reduction of both craving and eating behaviors with active ...