Using rTMS to improve sleep quality and mood

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

This study is testing if a treatment called rTMS can help improve sleep quality and mood in adults aged 22 to 70 who have sleep-related problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: Gerrish MedEsthetics (Industry-sponsored)
• Locations: 1 site (Vienna, Virginia)
• Trial ID: NCT06214871 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on sleep quality, mood, and memory in participants aged 22 to 70. The study aims to determine whether rTMS can enhance these aspects of mental health in individuals experiencing sleep-related issues. Participants will undergo rTMS treatment while their responses are monitored to assess improvements in their sleep and overall well-being.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 22 to 70 who experience sleep-related issues and meet specific inclusion criteria.

Not a fit: Patients with contraindications for TMS therapy or a history of significant head trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve sleep quality and mood for patients struggling with sleep disturbances.

How similar studies have performed: While the use of rTMS for various conditions has shown promise, this specific application for sleep enhancement is relatively novel and less tested.

Eligibility criteria

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.

Where this trial is running

Vienna, Virginia

• Gerrish MedEsthetics — Vienna, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Scott Gerrish

Conditions Sleep