rTMS for Neuroenhancement

Gerrish MedEsthetics

Status

Enrolling

Conditions

Sleep

Treatments

Device: rTMS

Study type

Interventional

Funder types

Industry

Identifiers

2023-001

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

22 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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)
Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.