A Prospective Study To Evaluate Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) For Neuroenhancement

Gerrish MedEsthetics1 site in 1 country30 target enrollmentNovember 7, 2023

ConditionsSleep

Overview

The purpose of this pilot study is to evaluate the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Sleep Quality, Mood and Memory.

Registry

clinicaltrials.gov

Start Date

November 7, 2023

End Date

November 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Gerrish MedEsthetics

Responsible Party

Sponsor

•Male or female, 22 to 70 years of age
•Freely provides written informed consent
•In good general health, as ascertained by medical history
•If female, not breastfeeding, no known or suspected pregnancy, a status of non- childbearing potential or use of an acceptable form of birth control
•If subject is in menopausal transition, the subject must be stabilized on hormonal treatment.
•Subject scored a 2 or higher on PHQ-9 sleep related question (#3), OR subject scored 2 or more on at least 2 QIDS-SR sleep related questions (#'s 1-4)
•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.

•Subject satisfies 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 which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation,
•Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
•Current diagnosis or known history of neurologic or neuropsychiatric disease (e.g., epilepsy, convulsion, seizure)

Sleep Quality - Jenkins Sleep Scale

Time Frame: Various - Over 8 weeks

Jenkins Sleep Scale (Score can be from 0-20; higher scores equal lesser sleep quality)

Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)

Time Frame: Various - Over 8 Weeks

PHQ-9 (Question #3 score can be 0-3; higher score equal lesser sleep quality)

Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)

Time Frame: Various - Over 8 Weeks

QIDS-SR (Questions #1-#4 each question can be 0-3; higher score equals lesser sleep quality)

Memory - RAVLT Delayed Recall(Various - Over 8 weeks)
Mood - PANAS (Positive and Negative Affect Schedule)(Various - Over 8 weeks)
Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)(Various - Over 8 weeks)
Mood - VAMS (Visual Analog Mood Scale)(Various - Over 8 Weeks)
Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey)(Various - Over 8 Weeks)