rTMS for Neuroenhancement

NCT06214871 | Unknown FDA Device

• 1 other identifier: 2023-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Mood - PANAS (Positive and Negative Affect Schedule)

  Various - Over 8 weeks

• Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)

  Various - Over 8 weeks

• Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey)

  Various - Over 8 Weeks

• Mood - VAMS (Visual Analog Mood Scale)

  Various - Over 8 Weeks

• Memory - RAVLT Delayed Recall

  Various - Over 8 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: rTMS

Interventions

rTMS DEVICE

Transcranial Magnetic Stimulation

Single Arm

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gerrish MedEsthetics: lead

Study Sites (1)

Gerrish MedEsthetics

Vienna, Virginia, 22180, United States

RECRUITING

Central Study Contacts

Scott Gerrish

CONTACT

703-255-5580; drgerrish@hotmail.com

Michele Duley

CONTACT

703-255-5580; michele@gerrishmedesthetics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 22, 2024
• Study Start: November 7, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)