RECRUITING

rTMS for Neuroenhancement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-11-07

Study Completion:2024-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06214871

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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. * 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.

Inclusion Criteria

Exclusion 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.

* 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.
* 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.

Contacts and Locations

Study Contact

Scott Gerrish

CONTACT

703-255-5580

drgerrish@hotmail.com

Michele Duley

CONTACT

703-255-5580

michele@gerrishmedesthetics.com

Study Locations (Sites)

Gerrish MedEsthetics

Vienna, Virginia, 22180

United States

Collaborators and Investigators

Sponsor: Gerrish MedEsthetics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07

Study Completion Date2024-11

Study Record Updates

Study Start Date2023-11-07

Study Completion Date2024-11

Terms related to this study

Additional Relevant MeSH Terms

Sleep