EXOMIND (BTL-699) for the Reduction of Food Cravings (NCT06889298) | Clinical Trial Compass
CompletedNot Applicable
EXOMIND (BTL-699) for the Reduction of Food Cravings
Czechia29 participantsStarted 2023-02-09
Plain-language summary
The goal of this clinical trial is to evaluate if the treatment with BTL-699 device is able to temporarily reduce food cravings in adults above the age of 22 years. The main question it aims to answer is:
Does the treatment with BTL-699 device provide a temporary reduction of food cravings?
Participants will be asked to:
* Undergo 4 to 6 treatments
* Undergo weight measurements
* Complete the Food Cravings Questionnaire-Trait
* Complete the Therapy Comfort Questionnaire
* Complete the Satisfaction Questionnaire
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* At least 3-5 self-reported episodes of food craving periods per week
* Age \> 22 years
* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb at least five out of 10 times
* Subjects willing and able to abstain from partaking in any other weight management treatments other than the study procedure during study participation
* Willingness to comply with study instructions and to return to the clinic for the required visits
Exclusion Criteria:
* Cochlear implants
* Intake disorders such as bulimia, anorexia
* Borderline personality disorder
* Other metal implants close to the application area (1 meter at least)
* Personal history of epilepsy
* Personal history of syncope
* Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
* Sleep deprivation
* Alcoholism
* Presence of a substance abuse or dependence (alcohol, caffeine, drugs) conditions associated with altered seizure risk
* Intake of one or a combination of the following drugs forms a strong potential hazard for the application of rTMS due to their significant seizure threshold lowering potential: imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencycli…