Clinical trial NCT06889298: BTL-699 for the Reduction of Food Cravings
Official title: Safety and Efficacy of the BTL-699 Device for Temporary Reduction of Food Cravings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Cravings
Keywords: rTMS
food cravings
weight reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 29
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: This study uses a single-center, single-arm, open-label, interventional design.

Subjects reporting at least 3 to 5 weekly instances of food cravings will be enrolled. All enrolled participants will receive 4 to 6 treatments with the BTL-699 device, administered 2 to 3 days apart. The required number of treatments for each participant will be determined on a case-by-case basis by the Principal Investigator, with a minimum of four sessions.

Therapy parameters will be adjusted based on patient feedback and comfort, up to 100% of the individual's motor threshold.

Examination for possible adverse effects will be assessed at each visit.

The Food Cravings Questionnaire-Trait will be administered before the first treatment, after the last treatment, and at the two follow-up visits-2 weeks and 1 month after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Satisfaction Questionnaire will be given after the last treatment and at both follow-up visits.

The total expected duration of subject participation, from the baseline visit to study completion, is approximately three months.

Eligibility criteria: 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), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline
* Intake of seizure threshold lowering drugs such as: mianserin, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, reboxetine, venlafaxine, duloxetine, bupropion, mirtazapine, fluphenazine, pimozide, haloperidol, olanzapine, quetiapine, aripiprazole, ziprasidone, risperidone, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, BCNU, lithium, anticholinergics, antihistamines, sympathomimetics
* Withdrawal from one of the following drugs could form a relative hazard for the application of rTMS due to the resulting significant seizure threshold lowering potential: alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrate
* Systemic infection, fever
* Patients with a broad range of neuropsychiatric diseases are at elevated risk for seizures. - Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers) are associated with an elevated risk for seizures
* Major depression (elevated seizure risk)
* Hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure
* Raised blood concentrations of pro-convulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections)
* Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
* Dialysis
* Bipolar Disorder
* Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
* Urine drug screen positive for amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and phencyclidine
* Implanted infusion pumps
* Intracardiac devices (pacemakers, heart valves, etc.)
* Contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified

Primary outcomes:
measure: Assessment of Change in Food Cravings
timeFrame: 15 months
Secondary outcomes:
measure: Assessment of Therapy Comfort
timeFrame: 15 months
measure: Assessment of Satisfaction
timeFrame: 15 months
measure: Incidence of Treatment-related Adverse Events
timeFrame: 15 months
Other outcomes:
Locations:
city: Klecany
country: Czechia
facility: National Institute for Mental Health
Study officials:
References: