The purpose of this study is to assess the ability of a form of non-invasive brain stimulation called personalized repetitive transcranial magnetic stimulation, or PrTMS, to enhance cognitive performance and sleep quality from baseline metrics.
Repetitive Transcranial Magnetic Stimulation (rTMS) is an FDA approved, non-invasive, non-pharmaceutical strategy for treating adults with major depression. This particular treatment strategy is also deemed safe and well-tolerated per the numerous clinical trials of over 300 patients. Additionally, the extant literature reports numerous occurrences of human performance enhancement in association with rTMS, such as better visual perception, motor learning, objective identification, attention, memory, as well as faster eye movements. However, recent advancements in rTMS yield promise for a more personalized protocol that is specific to individual needs and is based on quantitative electroencephalography (qEEG), enabling a correlation between qEEG and human behavior, though further investigation is necessary. Therefore, this study will examine personalized qEEG-guided rTMS (PrTMS) based upon each patient's pretreatment qEEG readings. PrTMS uses neural alpha wave dynamics to target its TMS intervention via PeakLogic software with respect to location and frequency of TMS application. If PrTMS is effective, then researchers should be able to observe specific changes, e.g., more consistent fundamental frequency and increased alpha wave coherence across multiple brain sites, as PrTMS interventions progress. More importantly, alpha wave coherence is known to be associated with improved sleep behavior, cognition, and emotional reactivity. Thus, it is reasonable to hypothesize that changes in neural activity (as detected via qEEG) may result in several positive behavioral and perceptual (e.g., improved mood state/reduced anxiety) responses even for healthy populations. The goal of PrTMS is to steadily nudge neural alpha wave responses towards a common fundamental frequency (10 to 12 Hz) across all brain regions. These frequencies vary over time, like all natural systems, with larger variations thought to be tied to behavioral symptomologies such as anxiety, PTSD, sleep disturbances and other conditions. Once this goal is achieved, neural activity across the brain is in coherence, which is assumed to be a natural and more efficient state for brain activity, with downstream effects such as the alleviation of symptoms relevant to brain-related disease/injury and/or heightened cognitive function. Provided the well understood importance of adequate sleep and keen cognition for both the quality of daily living as well as longevity, efforts to thwart any potential disturbances to either offers promise for the betterment of the RNI's targeted populations, AMP2 (Athletics, Military, Patient, and general Population communities). Further, there are very intimate associations between sleep and cognition; put simply, the more one sleeps and the better quality of said sleep, the better one's cognitive skills will be the subsequent day. Indeed, previous research reported improved attentional focus, cognitive processing, and memory development with greater sleep durations. Contrarily, when one is deprived of sleep, one might expect to experience decreased physical performance capabilities (e.g., decreased force production), deleterious effects to glucose metabolism, poor appetite, diminished protein synthesis at the cellular level, as well as increased systemic inflammation. One intriguing strategy for improving sleep and cognition that is both noninvasive and non-pharmaceutical is Transcranial Magnetic Stimulation (TMS). Previous literature suggests that Transcranial Magnetic Stimulation was effective in enhancing both sleep and cognitive performance3. Further, Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) demonstrated increased efficacy in TMS treatments through utilizing quantitative electroencephalography (qEEG) and fine tuning the treatment to the individual. Yet, research examining the integration of PrTMS with assessments of sleep and cognition is scarce. Therefore, the main objective of this proposed study is to investigate the use of PrTMS, utilizing qEEG weekly for individualization, and the effects on sleep, cognitive performance, and overall wellness in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States
Change in Nocturnal Heart Rate as measured by OURA Ring
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Heart rate variability (as measured by variance in time between heart beats) will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Sleep Latency as measured by OURA Ring
Sleep onset latency will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Sleep Score as measured by OURA Ring
Total sleep score will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Total Sleep Time as measured by OURA Ring
Time of sleep will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Sleep Efficiency as measured by OURA Ring
Sleep efficiency will be quantified throughout the night via the OURA ring.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Sleep Quality as measured via Questionnaire
A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants' smartphones within an hour of waking. Scores range from 3-10 with higher scores indicating poor sleep.
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Time frame: Daily from baseline through study completion at 6 weeks
Change in Recovery as measured via Questionnaire
A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants' smartphones within an hour of waking. Scores range from 4-24 with higher scores indicating better recovery.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Stress as measured via Questionnaire
A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants' smartphones within an hour of waking. Scores range from 4-24 with higher scores indicating more stress.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Sustained Attention and Reaction Time
The Psychomotor Vigilance Task will be administered each morning within an hour of waking. This task will be completed on the participants' smartphone. Performance is calculated as 100% minus the number of lapses or false starts.
Time frame: Daily from baseline through study completion at 6 weeks
Change in Subjective Sleep Quality measured via Questionnaire
Participants will complete the Sleep Condition Indicator weekly. Scores range from 0-32. Higher scores indicate better sleep.
Time frame: Weekly from baseline through study completion at 6 weeks.
Change in Subjective Attention measured via Questionnaire
Participants will complete the Adult ADHD Self-Report Scale three different times. Scores are grouped by 0-16 = unlikely to have ADHD, 17-23 = likely to have ADHD, 24 or greater = highly likely to have ADHD.
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
Change in Subjective Anxiety measured via Questionnaire
Participants will complete the Hamilton Anxiety Rating Scale (HAM-A) three different times. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
Change in Subjective Depression measured via Hamilton Depression Rating Scale
Participants will complete the Hamilton Depression Rating Scale (HAM-D) three different times. The higher the score, the more severe the symptoms of depression. 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
Change in Subjective Depression measured via Patient Health Questionnaire
Participants will complete the Patient Health Questionnaire (PHQ-9) three different times. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression.
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
Change in Subjective Anxiety measured via Questionnaire
Participants will complete the Generalzied Anxiety Disorder 7-item (GAD-7) scale weekly. Higher scores indicate anxious feelings. Scoring is grouped by 5-9 = mild, 10-14 = moderate, 15-21 = severe
Time frame: Weekly from baseline through study completion at 6 weeks
Change in Mood as Indicated via Questionnaire
A custom daily morning questionnaire will be used to record how a participant feels in regard to mood and vigilance. Scores range from 8-100 with higher scores indicating better overall mood and vigilance.
Time frame: Daily from baseline through study completion at 6 weeks