Can Transcranial Magnetic Stimulation Decrease Food Reinforcement

Recruiting in Palo Alto (17 mi)

Overseen byDale Bond, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Hartford Hospital

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Reduction in food reinforcement appears to be a principal way by which bariatric surgery lowers energy intake to promote weight loss and other health improvements. However, surgical modulation of mechanisms that influence food reinforcement is variable with some patients appearing more resistant to these effects than others. This "resistant" phenotype, characterized by high levels of hedonic hunger (i.e., eating for pleasure in the absence of hunger) and disinhibition (i.e., susceptibility to cues that promote overeating), can undermine surgical efficacy. Bariatric surgery patients who demonstrate this high-risk eating phenotype may benefit from strategies that can directly target neural mechanisms of food reinforcement. Repetitive transcranial magnetic stimulation (rTMS), a noninvasive procedure that delivers magnetic pulses to stimulate or inhibit nerve cells in the brain, has successfully been used to target dysregulated brain reward circuitry to diminish the reinforcing properties of addictive drugs, such as cocaine. rTMS might have a similar effect on people who have a strong drive to eat in response to the reward of palatable foods. No study has directly examined how rTMS impacts the reinforcing value of food and related brain reward processing among people who find food highly reinforcing. The reinforcing value of food can be measured by comparing how much work a person will choose to do to access that food versus an alternative reinforcer (i.e., relative-reinforcing value of food \[RRV\]). In this study, we aim to: (1) determine whether rTMS reduces the RRV relative to money; and (2) measure acute rTMS-induced modulation of reward processing with electroencephalography (EEG). Preoperative bariatric patients (n=10) will attend 2 study sessions, at least 1-week apart, with RRV and reward measures completed while EEG is collected before and after a rTMS session. With condition blinding and counterbalancing, participants will be randomized to active rTMS on one day and sham rTMS on the other day. Participants will arrive fasted in the morning, receive a standardized breakfast, complete the RRV and reward tasks during EEG before rTMS (pre-rTMS EEG), receive rTMS, then complete the RRV and reward tasks during EEG after rTMS (post-rTMS EEG). During the active condition, rTMS will be applied to the dorsolateral prefrontal cortex because this region is functionally and structurally connected to the striatum, an area necessary for reward processes. These procedures will allow for comparison of pre- to post-test rTMS changes in behavioral (RRV) and neural modulation (EEG) of food reward between the active and sham conditions.

Eligibility Criteria

This trial is for adults aged 18-60 who are planning to have bariatric surgery, can consent in English, and typically eat breakfast before 8 AM. They should not have cognitive impairments or ADHD, with an IQ of at least 80. Participants must also exhibit high levels of pleasure-driven eating and overeating susceptibility but meet safety standards for EEG and rTMS procedures.

Inclusion Criteria

Meet clinical criteria regarding hedonic hunger

Meet safety criteria for EEG and rTMS

I am between 18 and 60 years old.

+5 more

Exclusion Criteria

I have hearing loss or ringing in my ears due to loud noise.

I haven't had rTMS therapy for any reason in the last 6 months.

I have no history of neurological disorders or events that increase seizure risk.

+6 more

Participant Groups

The study tests if transcranial magnetic stimulation (rTMS) can reduce the desire to eat for pleasure rather than hunger among preoperative bariatric patients. It involves two sessions: one with real rTMS and another with sham (fake) treatment, both targeting the brain's reward centers while measuring food reinforcement value against money.

2Treatment groups

Experimental Treatment

Group I: Sequence 2Experimental Treatment1 Intervention

Sham TMS followed by TMS

Group II: Sequence 1Experimental Treatment1 Intervention

TMS followed by sham TMS

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Transcranial Magnetic Stimulation for: