Phase
Condition
N/ATreatment
rTMS
Clinical Study ID
Ages 22-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults, 22 to 70 years of age
Voluntarily provides written informed consent and agree to comply with studyprocedures, including attending all study visits and completing all studyassessments.
Score > or = 8 on ISI scale
If subject is on any psychiatric or sleep medication, dose must be stable for twoweeks prior to enrollment and remain stable throughout the trial.
If female, not breastfeeding, no known or suspected pregnancy, a status ofnonchildbearing potential or use of an acceptable form of birth control.
Subject on stable dose regime for other concurrent medications like hormonal therapyfor menopause transition etc.
Exclusion
Exclusion Criteria:
Subject meets any one or more of the contraindications for TMS Therapy per currenttreatment guidelines as determined by the PI.
History of head trauma associated with loss of consciousness or diagnosed asconcussion.
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/circumstancewhich, in the opinion of the investigator, might interfere with safety, studyparticipation, 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 definedby 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 likeObstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) asdefined by DSM-V-TR.
Has a clinically significant abnormality on the screening examination.
Participation in any clinical trial with an investigational drug or device withinthe past month or concurrent with study participation.
Study Design
Study Description
Connect with a study center
Charlotte Skin and Laser
Charlotte, North Carolina 28207
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.