Effects of rTMS on Food Choice in Anorexia Nervosa
ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorNew York State Psychiatric Institute
About this trial
This study will examine the impact of high-frequency repetitive transcranial magnetic stimulation on food choice behavior and related neural activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
DSM-5 Diagnosis of Anorexia Nervosa
Age 18-35 years
Female
Right-handed
Disqualifiers
High risk of suicide
Current substance use disorder or other co- morbid psychiatric condition requiring specialized treatment (e.g., psychosis)
Diagnosis of major medical or neurological problem or taking medication that significantly increases risk for seizure or affects interpretation of findings (e.g., unstable hypertension, seizure disorder)
Food restrictions (e.g., allergies) which impact greater than 30% of food choice task's choice options
Trial design
Design model
Parallel
Treatments tested in this trial
High-frequency repetitive transcranial magnetic stimulation (active rTMS)
DeviceHF-rTMS is applied with a figure-of-8 coil using the Magstim TMS System. Participants receive one administration of HF-rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). HF-rTMS is delivered at a frequency of 10 Hz for approximately 37 minutes (3000 total pulses).
Sham repetitive transcranial magnetic stimulation (sham rTMS)
DeviceSham rTMS is applied with a figure-of-8 sham coil using the Magstim TMS System, which is identical to the active coil, replicates the sounds of HF-rTMS, and is designed to mimic sensations of HF-rTMS. Participants receive one administration of sham rTMS, delivered to the region of the right dorsolateral prefrontal cortex (DLPFC) with greatest resting-state functional connectivity to the dorsal striatum (individualized per participant). Sham rTMS is delivered for approximately 37 minutes (3000 total pulses).
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: High-frequency repetitive transcranial magnetic stimulation (HF-rTMS)Experimental treatment 1 intervention
Group B: Sham repetitive transcranial magnetic stimulation (sham rTMS)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neural activity and functional connectivity during the food choice task
Change in: food choice-related BOLD activity within the dorsal striatum, food choice-related functional Change in: connectivity between the dorsal striatum and dorsolateral prefrontal cortex
Time frame
Baseline to post-treatment (approx. 1 week apart)2
Restrictive eating behavior during the food choice task
Change in: proportion of high-fat foods selected; proportion of trials in which participants had an opportunity to implement self-control; proportion of trials in which participants implemented self-control
Time frame
Baseline to post-treatment (approx. 1 week apart)Secondary outcomes
1
Predictors of HF-rTMS response
Association between resting-state functional connectivity and: neural activity and functional connectivity during the food choice task (primary outcome #1); restrictive eating behavior during the food choice task (primary outcome #2)
Time frame
Baseline to post-treatment (approx. 1 week apart)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
National Eating Disorders Association
Collaborator
Global Foundation for Eating Disorders
Collaborator
Source ClinicalTrials.gov