Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.

Inclusion criteria

• Adults, 22 to 70 years of age
• Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
• Score > or = 8 on ISI scale
• If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
• If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
• Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.

Exclusion criteria

• Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
• History of head trauma associated with loss of consciousness or diagnosed as concussion.
• History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
• Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
• Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
• Has medication infusion device.
• Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
• PHQ-9 total score > or = 10 or QIDS total score > or = 11.
• Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
• Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
• Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
• Has a clinically significant abnormality on the screening examination.
• Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.