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Completed

NCT Number: NCT06214871

rTMS for Neuroenhancement

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

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Key information

Conditions

Age range

22 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gerrish MedEsthetics

Vienna, Virginia, 22180, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS

Device

Transcranial Magnetic Stimulation

Primary outcomes

  1. Change in 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)

Secondary outcomes

  1. Change in Mood

    Time frame: Various - Over 8 weeks

    Assessments; - PANAS (Positive and Negative Affect Schedule) PANAS (20 Questions; The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect)

  2. Change in Memory

    Time frame: Various - Over 8 weeks

    Assessment;- RAVLT Immediate Recall (Rey Auditory Verbal Learning Test) RAVLT Immediate (the sum of scores from 5 first trials (Trials 1 to 5)),

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Gerrish MedEsthetics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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