Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-11-07
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
rTMS
Transcranial Magnetic Stimulation
Interventions
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rTMS
Transcranial Magnetic Stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
70 Years
ALL
Yes
Sponsors
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Gerrish MedEsthetics
INDUSTRY
Responsible Party
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Locations
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Gerrish MedEsthetics
Vienna, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-001
Identifier Type: -
Identifier Source: org_study_id
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