Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BTL Industries Ltd.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 22 years
A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening
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 pre-procedure therapy regime for the treatment of anxiety, including non-invasive brain stimulation treatments other than the study procedure 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 must be maintained on their pre-study psychotherapeutic regimen and any prescribed chronic medications at a stable therapeutic dose for ≥4 weeks prior to enrollment, with no dose or usage frequency changes permitted during the study
* Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
You may not be if
Metallic 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 or within 12 in (30 cm) of the treatment coil.\*
Implanted stimulator devices
Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death.
Drug pumps
Application in the heart area
Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)
Anticoagulation therapy
Severe or life-threatening condition
Pulmonary insufficiency
Heart disorders
Renal insufficiency
Decompensated\*\* hemorrhagic conditions
Decompensated\*\* blood coagulation disorders
Decompensated\*\* cardiovascular diseases
Malignant tumor or benign tumor
Fever
Pregnancy
Active suicidal intent\*\*\*
History of suicide attempts in the last 3 years
History or concurrent use of electroconvulsive therapy or vagus nerve stimulation
Substance-induced depression or depression secondary to a general medical condition
Seasonal affective disorder
Substance abuse
Substance dependence 3 months prior
A psychotic disorder including schizoaffective disorder, bipolar disease, borderline personality disorder or major depression with psychotic features
Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders
Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past fiscal year
History of increased intracranial pressure or head trauma
Nursing
Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study
* Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants, such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered.
* By means of decompensation, it means a patient with a proven medical history of a decompensated health condition and long-term medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure, are not considered contraindicated.
* Defined by a score of Level 4 or Level 5 on the Columbia-Suicide Severity Rating Scale (CSSRS).
Clareo Health | Device for Treating Generalized Anxiety
