Phase
Condition
Vomiting
Bulimia
Weight Loss
Treatment
Treatment with BTL-995-rTMS
Clinical Study ID
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Scoring more than 17 points based on the BES
Age > 22 years
Voluntarily signed informed consent
Ability to determine the motor threshold of the participant. The participant's motorthreshold could be established as the minimum stimulus required to inducecontraction of the right thumb
Subjects willing and able to abstain from partaking in any other weight managementtreatments other than the study procedure during study participation
Willingness to comply with study instructions and to return to the clinic for therequired visits
Women of child-bearing potential* are required to use birth control measures duringthe whole duration of the study
Exclusion
Exclusion Criteria:
Electronic implants (Implanted stimulator devices in or near the head - rTMS devicesare 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 injuryor death.
Metallic or other magnetic sensitive implants/objects in or near the head - rTMSdevices are contraindicated for use in patients who have conductive, ferromagneticor other magnetic-sensitive metals implanted in their head or within 30 cm of thetreatment coil. (Examples include implanted electrodes/stimulators, aneurysm clipsor coils, stents, bullet fragments, jewellery and hair barrettes. Failure to followthis restriction could result in serious injury or death.)
Drug pump(s)
Persons with a tendency to seizure (hypotonic, epileptic)
Ongoing anticoagulation therapy
Ongoing severe or life-threatening condition
Pulmonary insufficiency
Heart disorders
Renal insufficiency
Decompensated hemorrhagic conditions, blood coagulation disorders, cardiovasculardiseases
Malignant or benign tumour
Fever
Facial tattoos with metallic ink (within 30 cm of the treatment coil)
Pregnancy or nursing
Ongoing intake disorders such as bulimia or anorexia, borderline personalitydisorder, major depression (elevated seizure risk) or bipolar disorder Personalhistory of epilepsy
Personal history of syncope (except the reflex syncope)
Vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, evenwithout a history of seizure, and without anticonvulsant medication
Withdrawal from one of the following drugs could form a relative hazard for theapplication of rTMS due to the resulting significant seizure threshold loweringpotential: (e.g. alcohol, barbiturates, benzodiazepines, meprobamate, chloralhydrateetc.)
Systemic infection
Patients with a broad range of neuropsychiatric diseases are at elevated risk forseizures. Essentially all neurologic conditions with structural cerebral damage (e.g. stroke, multiple sclerosis, traumatic brain injury, Alzheimer's and otherneurodegenerative diseases, meningoencephalitis or intracerebral abscess,parenchymal or leptomeningeal cancers) are associated with an elevated risk forseizures
History of hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia,renal failure/uremia, liver failure
History of tendency for raised blood concentrations of pro-convulsant medicationsdue to reduced clearance (e.g. secondary to initiation of antibiotics for treatmentof infections)
Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that cancause the posterior reversible leukoencephalopathy syndrome
The use of amphetamines, barbiturates, cocaine metabolites, opiates andphencyclidine 72 hours before the therapy.
Contradictions for the testing used in the trial, for example, the motor thresholdcannot be found or quantified.
Study Design
Study Description
Connect with a study center
Medical Center "Intermedica"
Sofia, 1680
BulgariaSite Not Available
Medical Center "Intermedica"
Sofia 727011, 1680
BulgariaSite Not Available

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