Food CravingsNCT06889298
EXOMIND (BTL-699) for the Reduction of Food Cravings
A study testing Treatment with BTL-699 in people with Food Cravings, run by BTL Industries Ltd. at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Cravings
- What is being tested?
- Treatment with BTL-699
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCzechia
- Study dates
- 9 Feb 2023to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of the BTL-699 Device for Temporary Reduction of Food Cravings
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
Read the 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.
- Conditions
- Food Cravings
- Being tested
- Treatment with BTL-699
- Keywords
- rTMS, food cravings, weight reduction, ExoTMS, EXOMIND
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-699Device
Also called EXOMIND (BTL-995) with ExoTMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-699 | Experimental | Transcranial magnetic stimulation treatments with the BTL-699 device Receives: Device: Treatment with BTL-699 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (3)
Assessment of Therapy Comfort
Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. The Therapy Comfort questionnaire will be administered after the last treatment. Therapy Comfort questionnaire consists of the question "I found the treatment comfortable", to which responses are based on a 5-point Likert scale (1 = "strongly disagree", and 5 = "strongly agree") and the 10-point Numeric Analog Scale for pain (0 = no pain, 10 = worst possible pain"). A higher score for the statement "I found the treatment comfortable", and lower score on the Numeric Analog Scale for pain indicate higher therapy comfort.
Measured: 15 months
Assessment of Satisfaction
Subject Satisfaction with treatment outcomes will be assessed using 5-point Likert Scale Satisfaction questionnaire. The questionnaire will be administered after the last treatment, at the 2-week and 1-month follow-up visits. Responses to questions about satisfaction with the treatment outcomes will range from "strongly agree" (5 points) to "strongly disagree" (1 point). A higher score for each statement indicate better outcomes.
Measured: 15 months
Incidence of Treatment-related Adverse Events
Monitoring of adverse reactions and side effects will be performed for the evaluation of safety of the treatment with the BTL-699 device for the reduction of food cravings and to identify side effects and adverse events associated with the study treatment.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start9 Feb 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food CravingsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889298
- Sponsor's protocol ID
- BTL-699_CTCZ100
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BTL-699 Device for Temporary Reduction of Food Cravings
- ClinicalTrials.gov ID
- NCT06889298
- Acronym / sponsor ID
- BTL-699_CTCZ100
- Conditions
- Food Cravings
- Keywords
- rTMS, food cravings, weight reduction, ExoTMS, EXOMIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-699 | Experimental | Device: Treatment with BTL-699Transcranial magnetic stimulation treatments with the BTL-699 device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BTL-699Also: EXOMIND (BTL-995) with ExoTMSFour 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. | Device | Treatment with BTL-699 |
Primary outcome
Assessment of Change in Food Cravings
Time frame: 15 months
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.
3 secondary outcomes
Assessment of Therapy Comfort
Time frame: 15 months
Assessment of Satisfaction
Time frame: 15 months
Incidence of Treatment-related Adverse Events
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Related trials for Food Cravings
RecruitingPhase 1
Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
Alcohol Use Disorder (AUD), Obesity (BMI Equal to or >30)
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
Recruiting
The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain
Schizophrenia Spectrum, Schizophrenia
Recruiting
Physiological and Neurocognitive Responses to Multisensory Food Cues in VR
Healthy Participants
Not yet recruiting
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
GLP - 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-699 in people with Food Cravings, run by BTL Industries Ltd. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Change in Food Cravings (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.