Ultrasonic Treatment for Food Addiction
(USFADD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Utah
Disqualifiers: Serious suicide attempt, MRI intolerance, Pregnant, Diabetic, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
What data supports the effectiveness of the Ultrasonic Treatment for Food Addiction?
While there is no direct evidence for ultrasonic treatment, similar non-invasive brain stimulation techniques like transcranial direct current stimulation (tDCS) have shown promise in reducing food cravings and consumption in people with eating disorders and obesity. These techniques work by modulating brain activity, which may help control food-related behaviors.12345
How is Ultrasonic Treatment different from other treatments for food addiction?
Ultrasonic Treatment, or Low-Intensity Transcranial Focused Ultrasound Stimulation (LIFU), is unique because it uses sound waves to non-invasively target specific brain areas, potentially altering brain activity related to food cravings. Unlike other non-invasive brain stimulation methods like tDCS or rTMS, which use electrical or magnetic fields, LIFU uses focused ultrasound, which may offer more precise targeting of brain regions involved in food addiction.15678
Eligibility Criteria
This trial is for individuals who struggle with compulsive eating and obesity, having a BMI of at least 30 kg/m^2, or at least 25 kg/m^2 with related health issues like high blood pressure. Participants should have tried to lose weight through dieting without success.Inclusion Criteria
History of at least one self-reported unsuccessful dietary effort to lose body weight
My BMI is 30 or higher, or it's 25 or higher with a condition like high blood pressure.
Exclusion Criteria
Lifetime history of a serious suicide attempt
MRI intolerance or contraindication
Pregnant or breast feeding
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive low-intensity transcranial focused ultrasound stimulation or sham stimulation for food addiction
16 weeks
16 visits (in-person, weekly)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Ultrasonic Treatment (Procedure)
Trial OverviewThe study tests a non-invasive brain therapy using ultrasonic waves aimed at treating food addiction. It involves comparing active ultrasonic stimulation against sham (fake) treatment to see if it affects cravings and weight loss, monitored by MRI scans and questionnaires.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active stimulationActive Control1 Intervention
Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Group II: Sham stimulationPlacebo Group1 Intervention
Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
Clinical Utility of Add-On Transcranial Direct Current Stimulation for Binge Eating Disorder with Obesity in Schizophrenia. [2020]Over the recent years, there has been an increasing application of noninvasive brain stimulation techniques such as transcranial direct-current stimulation (tDCS) to modify eating behaviors in healthy population and persons with eating disorders. tDCS is a noninvasive, neuromodulatory intervention which is well-tolerated and safe. In this case report, we describe the successful application of add-on tDCS in a patient with schizophrenia to reduce the craving for food that in turn, helped in reversing the weight gain.
Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. [2022]To investigate the effect of transcranial direct current stimulation (tDCS) on food craving, intake, binge eating desire, and binge eating frequency in individuals with binge eating disorder (BED).
The critical role of cognitive-based trait differences in transcranial direct current stimulation (tDCS) suppression of food craving and eating in frank obesity. [2022]Obesity remains a major public health concern and novel treatments are needed. Transcranial direct current stimulation (tDCS) is a neuromodulation technique shown to reduce food craving and consumption, especially when targeting the dorsolateral prefrontal cortex (DLPFC) with a right anode/left cathode electrode montage. Despite the implications to treat frank (non-bingeeating) obesity, no study has tested the right anode/left cathode montage in this population. Additionally, most tDCS appetite studies have not controlled for differences in traits under DLPFC control that may influence how well one responds to tDCS. Hence, N = 18 (10F/8M) adults with frank obesity completed the Dutch Eating Behavior Questionnaire-Restraint and Barratt Impulsiveness Scale, and received 20 min of 2 mA active tDCS and control tDCS session. Craving and eating was assessed at both sessions with a food photo "wanting" test and in-lab measures of total, preferred, and less-preferred kilocalories consumed of three highly palatable snack foods. While main effects of tDCS vs. control were not found, significant differences emerged when trait scores were controlled. tDCS reduced food craving in females with lower attention-type impulsiveness (p = 0.047), reduced preferred-food consumption in males with lower intent to restrict calories (p = 0.024), and reduced total food consumption in males with higher non-planning-type impulsiveness (p = 0.009) compared to control tDCS. This is the first study to find significant reductions in food craving and consumption in a sample with frank obesity using the most popular tDCS montage in appetite studies. The results also highlight the cognitive-based heterogeneity of individuals with obesity and the importance of considering these differences when evaluating the efficacy of DLPFC-targeted tDCS in future studies aimed at treating obesity.
Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. [2023]Functional, molecular and genetic neuroimaging has highlighted the existence of brain anomalies and neural vulnerability factors related to obesity and eating disorders such as binge eating or anorexia nervosa. In particular, decreased basal metabolism in the prefrontal cortex and striatum as well as dopaminergic alterations have been described in obese subjects, in parallel with increased activation of reward brain areas in response to palatable food cues. Elevated reward region responsivity may trigger food craving and predict future weight gain. This opens the way to prevention studies using functional and molecular neuroimaging to perform early diagnostics and to phenotype subjects at risk by exploring different neurobehavioral dimensions of the food choices and motivation processes. In the first part of this review, advantages and limitations of neuroimaging techniques, such as functional magnetic resonance imaging (fMRI), positron emission tomography (PET), single photon emission computed tomography (SPECT), pharmacogenetic fMRI and functional near-infrared spectroscopy (fNIRS) will be discussed in the context of recent work dealing with eating behavior, with a particular focus on obesity. In the second part of the review, non-invasive strategies to modulate food-related brain processes and functions will be presented. At the leading edge of non-invasive brain-based technologies is real-time fMRI (rtfMRI) neurofeedback, which is a powerful tool to better understand the complexity of human brain-behavior relationships. rtfMRI, alone or when combined with other techniques and tools such as EEG and cognitive therapy, could be used to alter neural plasticity and learned behavior to optimize and/or restore healthy cognition and eating behavior. Other promising non-invasive neuromodulation approaches being explored are repetitive transcranial magnetic stimulation (rTMS) and transcranial direct-current stimulation (tDCS). Converging evidence points at the value of these non-invasive neuromodulation strategies to study basic mechanisms underlying eating behavior and to treat its disorders. Both of these approaches will be compared in light of recent work in this field, while addressing technical and practical questions. The third part of this review will be dedicated to invasive neuromodulation strategies, such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS). In combination with neuroimaging approaches, these techniques are promising experimental tools to unravel the intricate relationships between homeostatic and hedonic brain circuits. Their potential as additional therapeutic tools to combat pharmacorefractory morbid obesity or acute eating disorders will be discussed, in terms of technical challenges, applicability and ethics. In a general discussion, we will put the brain at the core of fundamental research, prevention and therapy in the context of obesity and eating disorders. First, we will discuss the possibility to identify new biological markers of brain functions. Second, we will highlight the potential of neuroimaging and neuromodulation in individualized medicine. Third, we will introduce the ethical questions that are concomitant to the emergence of new neuromodulation therapies.
Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. [2018]To describe the state of the human research literature pertaining to the use of non-invasive brain stimulation (NIBS) procedures for modulating food cravings, food consumption, and treating disorders of eating (i.e., obesity, bulimia nervosa, and anorexia nervosa).
Physical Therapy. [2018]Physical therapy has the evidence-based science knowledge to address a wide range of physical and psychological problems of addiction. Neuromodulation techniques are becoming more and more important in the treatment of addiction. Here, the efficacy of different neuromodulation techniques in addiction, such as transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), deep brain stimulation (DBS), is critically evaluated. Other physical therapy methods including Biofeedback, Physical Activity and Acupuncture are also presented.
Invasive and Non-invasive Stimulation of the Obese Human Brain. [2020]Accumulating evidence suggests that non-invasive and invasive brain stimulation may reduce food craving and calorie consumption rendering these techniques potential treatment options for obesity. Non-invasive transcranial direct current stimulation (tDCS) or repetitive transcranial magnet stimulation (rTMS) are used to modulate activity in superficially located executive control regions, such as the dorsolateral prefrontal cortex (DLPFC). Modulation of the DLPFC's activity may alter executive functioning and food reward processing in interconnected dopamine-rich regions such as the striatum or orbitofrontal cortex. Modulation of reward processing can also be achieved by invasive deep brain stimulation (DBS) targeting the nucleus accumbens. Another target for DBS is the lateral hypothalamic area potentially leading to improved energy expenditure. To date, available evidence is, however, restricted to few exceptional cases of morbid obesity. The vagal nerve plays a crucial role in signaling the homeostatic demand to the brain. Invasive or non-invasive vagal nerve stimulation (VNS) is thus assumed to reduce appetite, rendering VNS another possible treatment option for obesity. Based on currently available evidence, the U.S. Food and Drug Administration recently approved VNS for the treatment of obesity. This review summarizes scientific evidence regarding these techniques' efficacy in modulating food craving and calorie intake. It is time for large controlled clinical trials that are necessary to translate currently available research discoveries into patient care.
Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. [2018]The dorsolateral prefrontal cortex (DLPFC) plays an important role in the regulation of food intake. Several previous studies demonstrated that a single session of transcranial direct current stimulation (tDCS) of the DLPFC reduces food craving and caloric intake.