rTMS for Neuroenhancement

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214871
• Other study ID #: 2023-001
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Gerrish MedEsthetics
• Contact: Scott Gerrish
• Phone: 703-255-5580
• Email: drgerrish[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Device:
• rTMS
Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
United States	Gerrish MedEsthetics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Gerrish MedEsthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality - Jenkins Sleep Scale	Jenkins Sleep Scale (Score can be from 0-20; higher scores equal lesser sleep quality)	Various - Over 8 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Memory - RAVLT Delayed Recall	RAVLT Forgetting (the score of Trial 5 minus score of the delayed recall)	Various - Over 8 weeks