Safety and Efficacy of Synchronized Transcranial Magnetic Stimulation for the Treatment of Generalized Anxiety Disorder

Exclusion Criteria

• •1. Subjects are unable or unwilling to give informed consent.
• •2. Primary Diagnosis with the following conditions confirmed by MINI (current unless otherwise stated):
• •1. GAD secondary to a general medical condition, or substance-induced.
• •2. History of substance abuse or dependence within the past 6 months (except nicotine and caffeine).
• •3. Major depressive disorder, bipolar disorder or psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes.
• •4. Eating disorder (current or within the past year).
• •5. Obsessive compulsive disorder (lifetime).
• •6. Post-traumatic stress disorder (current or within the past year).
• •7. Attention Deficit Hyperactivity Disorder (ADHD) currently being treated.
• •3. Subjects meeting criteria for Axis II cluster A or B diagnosis based upon Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria, which in the judgment of the Investigator may hinder the subjects in completing the procedures required by the study protocol.
• •4. Subjects with a clinically defined neurological disorder including, but not limited to:
• •1. Any condition likely to be associated with increased intracranial pressure.
• •2. Space occupying brain lesion.
• •3. Any history of seizure EXCEPT those therapeutically induced by Electroconvulsive Therapy (ECT). Childhood febrile seizures are acceptable and these subjects may be included in the study.
• •4. History of stroke.
• •5. Transient ischemic attack within two years.
• •6. Cerebral aneurysm.
• •7. Dementia (Montreal Cognition Assessment score less than 23).
• •8. Parkinson's disease.
• •9. Huntington's disease.
• •10. Multiple sclerosis.
• •11. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
• •5. Subjects with any of the following treatment histories:
• •1. TMS within 4 weeks prior to the screening visit or any prior treatment with sTMS
• •2. ECT treatment within 1 year prior to the screening visit.
• •3. Failure to respond to TMS or ECT treatment (i.e., consistent with Antidepressant Treatment History Form confidence level 3 or higher) in this or any previous episode.
• •4. Lifetime history of treatment with Deep Brain Stimulation (DBS) or Vagus Nerve Stimulation (VNS).
• •5. Use of any investigational drug or device within 6 months of the screening visit.
• •6. Subjects are adequately benefiting from current antianxiety medication(s)
• •7. Significant acute suicide risk as judged by the investigator
• •8. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
• •9. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
• •10. Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
• •11. Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
• •12. Positive urine drug screen for illicit substances. (A positive urine drug screen at screening may be repeated once prior to randomization).
• •13. Any condition which in the judgment of the Investigator would prevent the subject from completion of the study.