Identifying Networks Underlying Compulsivity in Anorexia Nervosa for Targeting With Neuromodulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 75
Healthy Volunteers: f
View:

• outpatients

• ages 16 - 75 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Andrew M Lee, MD, PhD
AndrewMoses.Lee@ucsf.edu
415-476-7000
Backup
Sasha Gorrell, PhD
Sasha.Gorrell@ucsf.edu
415-502-2716
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2025-09
Participants
Target number of participants: 20
Treatments
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.
Sponsors
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov