Clinical trial NCT06214871: rTMS for Neuroenhancement
Official title: A Prospective Study To Evaluate Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) For Neuroenhancement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Gerrish MedEsthetics
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Sleep Quality - Jenkins Sleep Scale
timeFrame: Various - Over 8 weeks
measure: Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)
timeFrame: Various - Over 8 Weeks
measure: Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)
timeFrame: Various - Over 8 Weeks
Secondary outcomes:
measure: Mood - PANAS (Positive and Negative Affect Schedule)
timeFrame: Various - Over 8 weeks
measure: Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)
timeFrame: Various - Over 8 weeks
measure: Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey)
timeFrame: Various - Over 8 Weeks
measure: Mood - VAMS (Visual Analog Mood Scale)
timeFrame: Various - Over 8 Weeks
measure: Memory - RAVLT Delayed Recall
timeFrame: Various - Over 8 weeks
Other outcomes:
Locations:
city: Vienna
country: United States
facility: Gerrish MedEsthetics
state: Virginia
Study officials:
References: