Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT07024550
Eligibility Criteria:
Inclusion Criteria:
* Age \> 19 years
* Any self-reported excessive overeating episodes in the last 2 months
* The minimal pre-treatment FCQ-T score of 100 points
* 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 ten times
* Subjects willing and able to abstain from partaking in any other weight management procedures (including diet and exercise regime changes) other than the study procedure during the study participation
* Subjects willing and able to abstain from initiating any other eating disorder treatments other than the study procedure during the study participation
* Subjects willing and able to undergo fMRI scanning, structural MRI scanning, and EEG recording, and proceed with the instructions from the study staff during the measurement
* 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 maintain pre-study prescribed medications at a stable therapeutic dosage and/or with maintained frequency of psychotherapy during the study participation. The pre-study treatment regime needs to be set and maintained for at least 2 months prior to the study enrollment
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 implants, and vagus nerve stimulators, implanted devices such as cardiac pacemakers, defibrillators, and neurostimulator.)
* metallic, ferromagnetic or other magnetic-sensitive implants/objects in or near the head - rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head (with some exceptions in the mouth - see the Safety Precautions and Warnings) or within 30 cm of the treatment coil. (Examples include implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewellery, and hair barrettes).
* application in the heart area
* persons with a tendency to seizure (hypotonic, epileptic)
* ongoing anticoagulation therapy
* ongoing severe or life-threatening condition
* ongoing renal dialysis therapy or decompensated renal insufficiency
* decompensated hemorrhagic conditions, blood coagulation disorders, cardiovascular diseases
* malignant or benign tumour (within 30 cm of the treatment coil)
* fever
* application over or in the near proximity (within 30 cm of the treatment coil) of tattoos with metallic ink
* Shrapnel or other metal or electronic implants (pacemakers, surgical devices, metallic tattoos on the head, etc.)
* pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
* history of head trauma, increased intracranial pressure or fainting
* major medical, neurological, or psychological disorders (e.g. depression, panic attacks, ADHD, tumors, heart conditions, claustrophobia)
* current usage of sleeping aids, painkillers (including aspirin), or other agents known to affect brain function (e.g. antihistamines, decongestants)
* any other contraindications for MRI examination
* 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, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines (MDMA, ecstasy), cocaine, 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
* suicidal tendencies or recent attempt to commit suicide
* concurrent use of electroconvulsive therapy or vagus nerve stimulation
* other intake disorders such as bulimia, anorexia
* vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication
* systemic infection
* patients with a broad 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
* immunosuppressive therapy with tacrolimus, and other agents which can cause the posterior reversible leukoencephalopathy syndrome
* diagnosis of post-traumatic stress disorder, psychotic disorder or current psychotic symptoms, bipolar disorder, borderline personality disorder
* pulmonary insufficiency
* heart disorders
* personal history of syncope (except the reflex syncope)
* implanted infusion pumps, drug pumps (within 30 cm of the treatment coil)
* contradictions for the testing used in the trial, for example, the motor threshold cannot be found or quantified
* any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07024550
Study Brief:
Protocol Section:
NCT07024550