EXOMIND (BTL-699) for the Reduction of Food Cravings

NCT06889298 | Completed

• 1 other identifier: BTL-699_CTCZ100
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Food Cravings

Keywords

rTMS; food cravings; weight reduction; ExoTMS; EXOMIND

Outcome Measures

Primary Outcomes (1)

• Assessment of Change in Food Cravings

  The change in the score obtained from the Food Cravings Questionnaire-Trait will be recorded. The questionnaire will be administered at the baseline visit, after the last treatment, at the 2-week and 1-month follow-up visits. The score ranges from 39 to 234 and higher scores indicate more frequent and intense food cravings in general. An improvement is defined as a decrease in score.

  15 months

Secondary Outcomes (3)

• Assessment of Therapy Comfort

  15 months

• Assessment of Satisfaction

  15 months

• Incidence of Treatment-related Adverse Events

  15 months

Study Arms (1)

Treatment with BTL-699

EXPERIMENTAL

Transcranial magnetic stimulation treatments with the BTL-699 device

Device: Treatment with BTL-699

Interventions

Treatment with BTL-699 DEVICE

Four to six transcranial magnetic stimulation treatments with the BTL-699 device will be delivered over the left dorsolateral prefrontal cortex, spaced 2 to 3 days apart. The intensity will be adjusted according to the subject's feedback, up to 100% of the individual's motor threshold.

Also known as: EXOMIND (BTL-995) with ExoTMS

Treatment with BTL-699

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

National Institute for Mental Health

Klecany, 250 67, Czechia

Location

MeSH Terms

Conditions

Weight Loss

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: February 9, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: September 17, 2025

Record last verified: 2025-03

Locations

CZ (1)