COMPLETED

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

Conditions

Self-Control Food Cravings willpower rTMS ExoTMS EXOMIND

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-01

Study Completion:2025-10-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT07056036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

Aria Integrative Health

Denver, Colorado, 80211

United States

A New You Wellness

Miami, Florida, 33156

United States

Cady Wellness Institute

Newburgh, Indiana, 47630

United States

Jiva Med Spa

Columbus, Ohio, 43215

United States

Collaborators and Investigators

Sponsor: BTL Industries Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-10-10

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-10-10

Terms related to this study

Keywords Provided by Researchers

self-control
willpower
food cravings
rTMS
ExoTMS
EXOMIND

Additional Relevant MeSH Terms

Self-Control
Food Cravings