rTMS for Neuroenhancement

A Prospective Study To Evaluate Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation (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.

Study Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Device: rTMS

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Gerrish; Phone Number: 703-255-5580; Email: drgerrish@hotmail.com
• Study Contact Backup: Name: Michele Duley; Phone Number: 703-255-5580; Email: michele@gerrishmedesthetics.com

Study Locations

• United States
  • Virginia
    • Vienna, Virginia, United States, 22180
      • Recruiting
      • Gerrish MedEsthetics
      • Contact: Scott Gerrish; Phone Number: 703-255-5580; Email: drgerrish@hotmail.com
      • Contact: Michele Duley; Phone Number: 703-255-5580; Email: michele@gerrishmedesthetics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Device: rTMS; Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality - Jenkins Sleep Scale	Jenkins Sleep Scale (Score can be from 0-20; higher scores equal lesser sleep quality)	Various - Over 8 weeks
Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)	PHQ-9 (Question #3 score can be 0-3; higher score equal lesser sleep quality)	Various - Over 8 Weeks
Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)	QIDS-SR (Questions #1-#4 each question can be 0-3; higher score equals lesser sleep quality)	Various - Over 8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory - RAVLT Delayed Recall	RAVLT Forgetting (the score of Trial 5 minus score of the delayed recall)	Various - Over 8 weeks
Mood - PANAS (Positive and Negative Affect Schedule)	Assessments; 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)	Various - Over 8 weeks
Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)	Assessment; RAVLT Immediate (the sum of scores from 5 first trials (Trials 1 to 5)),	Various - Over 8 weeks
Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey)	SAMMS (8 Questions; Total score ranges from 0-80; 2 of the questions are related to Mood and a higher score is better mood)	Various - Over 8 Weeks
Mood - VAMS (Visual Analog Mood Scale)	VAMS (7 Questions; Total score can range from 0-70; higher scores represent better Mood)	Various - Over 8 Weeks

Collaborators and Investigators

• Sponsor: Gerrish MedEsthetics

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-001 (Other Identifier: University of Missouri)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No