EXOMIND (BTL-699-2) for the Improvement in Willpower & Food Cravings

Safety and Efficacy of BTL-699-2 for the Improvement in Willpower, Self-control & Food Cravings

The goal of this clinical trial is to evaluate if the treatment with ExoMIND (BTL-699-2) device is able to improve willpower, self-control and food cravings in adults above the age of 22 years. The main question it aims to answer is:

Does the treatment with EXOMIND (BTL-699-2) device improve willpower, self-control and food cravings?

Participants will be asked to:

• Undergo six treatments
• Complete the Brief Self-control Scale
• Complete the Food Cravings Questionnaire - Trait
• Complete the Therapy Comfort Questionnaire
• Complete the Subject Satisfaction Questionnaire

This study uses a prospective, multi-center, two-arm, sham-controlled, single-blinded interventional study design.

The subjects will be enrolled and assigned to two experimental study arms: the active group (Group A) and the sham group (Group B), in a ratio of 3:1. All enrolled participants will be treated (either active or sham) with the BTL-699-2 device. Group A will receive rTMS treatment with an intensity of up to 70% of their MT, while Group B will receive rTMS treatment with an intensity of 5% of their MT. Six (6) treatments will be delivered, 3-7 days apart. Examination for possible adverse effects will be conducted after each treatment.

The Brief Self-Control Scale and the Food Cravings Questionnaire - Trait (FCQ-T) will be administered to the subjects before the first treatment, after the last treatment, and at the two follow-up visits-1 month and 3 months after the final session.

The Therapy Comfort Questionnaire will be administered after the last treatment, while the Subject 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 five months.

Inclusion Criteria:

• 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
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure for the improvement of willpower and self-control and rI eduction of food cravings, including non-invasive brain stimulation treatments other than the study procedure during study participation
• Subjects willing and able to maintain their regular (pre-procedure) exercise regimen without affecting significant change in either direction during study participation
• Willingness to comply with study instructions and to return to the clinic for the required visits
• Women of child-bearing potential* are required to use birth control measures during the whole duration of the study
• If applicable, subjects will be maintained on pre-study prescribed medications at a stable therapeutic dosage for at least 2 months prior to study entry

Exclusion Criteria:

• Electronic implants (Implanted stimulator devices in or near the head - rTMS devices are contraindicated for use in patients who have active or inactive implants (including device leads), deep brain stimulators, cochlear implants, ocular implant, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, neurostimulators. Contraindicated use could result in serious injury or death.
• Metallic, conductive, ferromagnetic or other magnetic sensitive implants/objects in the head or within 30 cm of the treatment coil (examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes) with some exceptions in the mouth as standard amalgam dental fillings, single post dental implants, and dental bridge work. Failure to follow this restriction could result in serious injury or death.
• Drug pump(s)
• Application in the heart area
• Persons with a tendency to seizure (hypotonic, epileptic), or a personal history of epilepsy
• Ongoing anticoagulation therapy
• Ongoing severe or life-threatening condition
• Pulmonary insufficiency
• Heart disorders
• Renal insufficiency
• Decompensated* hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
• Malignant or benign tumor
• Fever
• Ongoing pregnancy or nursing
• Ongoing intake disorders such as bulimia or anorexia
• Diagnosis of major depression, depression, post-traumatic stress disorder, psychotic disorder or current psychotic symptoms, bipolar disorder, obsessive-compulsive disorder, borderline personality disorder
• Personal history of syncope (except the reflex syncope)
• Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
• 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: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrate etc.)
• Systemic infection
• 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)
• History of hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure
• History of tendency for raised blood concentrations of pro-convulsant medications due to reduced clearance
• Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome
• The use of methamphetamine, barbiturates, cocaine metabolites, opiates and phencyclidine 72 hours before the therapy
• Contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified.