Phase
Condition
N/ATreatment
ActiveTreatment with BTL-699-2
Sham Treatment with BTL-699-2
Clinical Study ID
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age > 22 years
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 treatments other than thestudy procedure for the improvement of willpower and self-control and rI eduction offood cravings, including non-invasive brain stimulation treatments other than thestudy procedure during study participation
Subjects willing and able to maintain their regular (pre-procedure) exercise regimenwithout affecting significant change in either direction 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
If applicable, subjects will be maintained on pre-study prescribed medications at astable therapeutic dosage for at least 2 months prior to study entry
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, conductive, ferromagnetic or other magnetic sensitive implants/objects inthe head or within 30 cm of the treatment coil (examples include implantedelectrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelryand hair barrettes) with some exceptions in the mouth as standard amalgam dentalfillings, single post dental implants, and dental bridge work. Failure to followthis 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 ofepilepsy
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 tumor
Fever
Ongoing pregnancy or nursing
Ongoing intake disorders such as bulimia or anorexia
Diagnosis of major depression, depression, post-traumatic stress disorder, psychoticdisorder or current psychotic symptoms, bipolar disorder, obsessive-compulsivedisorder, borderline personality disorder
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)
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
Immunosuppressive therapy with cyclosporine, tacrolimus and other agents that cancause the posterior reversible leukoencephalopathy syndrome
The use of methamphetamine, 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
Aria Integrative Health
Denver, Colorado 80211
United StatesActive - Recruiting
A New You Wellness
Miami, Florida 33156
United StatesActive - Recruiting
Cady Wellness Institute
Newburgh, Indiana 47630
United StatesActive - Recruiting
Jiva Med Spa
Columbus, Ohio 43215
United StatesActive - Recruiting
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