Status:
COMPLETED
EXOMIND (BTL-699) for the Reduction of Food Cravings
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Food Cravings
Eligibility:
All Genders
22+ years
Phase:
NA
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...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06889298
Start Date
February 9 2023
End Date
June 20 2023
Last Update
September 17 2025
Active Locations (1)
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1
National Institute for Mental Health
Klecany, Czechia, 250 67