rTMS for Neuroenhancement
- Conditions
- Sleep
- Interventions
- Device: rTMS
- Registration Number
- NCT06214871
- Lead Sponsor
- Gerrish MedEsthetics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
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Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
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History of head trauma associated with loss of consciousness or diagnosed as concussion.
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History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
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Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
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Has an implanted stimulator device (including device leads) in or near the head.
(e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
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Has medication infusion device.
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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,
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Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
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Current diagnosis or known history of neurologic or neuropsychiatric disease (e.g., epilepsy, convulsion, seizure)
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Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
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Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm rTMS -
- Primary Outcome Measures
Name Time Method Sleep Quality - Jenkins Sleep Scale Various - Over 8 weeks Jenkins Sleep Scale (Score can be from 0-20; higher scores equal lesser sleep quality)
Sleep Quality - PHQ-9 (Patient Health Questionnaire-9) Various - Over 8 Weeks PHQ-9 (Question #3 score can be 0-3; higher score equal lesser sleep quality)
Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report) Various - Over 8 Weeks QIDS-SR (Questions #1-#4 each question can be 0-3; higher score equals lesser sleep quality)
- Secondary Outcome Measures
Name Time Method Memory - RAVLT Delayed Recall Various - Over 8 weeks RAVLT Forgetting (the score of Trial 5 minus score of the delayed recall)
Mood - VAMS (Visual Analog Mood Scale) Various - Over 8 Weeks VAMS (7 Questions; Total score can range from 0-70; higher scores represent better Mood)
Mood - PANAS (Positive and Negative Affect Schedule) Various - Over 8 weeks 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)
Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test) Various - Over 8 weeks Assessment; RAVLT Immediate (the sum of scores from 5 first trials (Trials 1 to 5)),
Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey) Various - Over 8 Weeks SAMMS (8 Questions; Total score ranges from 0-80; 2 of the questions are related to Mood and a higher score is better mood)
Trial Locations
- Locations (1)
Gerrish MedEsthetics
🇺🇸Vienna, Virginia, United States