Status:
RECRUITING
rTMS for Neuroenhancement
Lead Sponsor:
Gerrish MedEsthetics
Conditions:
Sleep
Eligibility:
All Genders
22-70 years
Phase:
NA
Brief Summary
The purpose of this pilot study is to evaluate the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Sleep Quality, Mood and Memory.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06214871
Start Date
November 7 2023
End Date
November 1 2024
Last Update
January 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gerrish MedEsthetics
Vienna, Virginia, United States, 22180