Sleep QualityNCT05353244
Effects of PrTMS on Performance
A study testing PrTMS in people with Sleep Quality and Cognition Improvement, run by West Virginia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Cognition Improvement
- What is being tested?
- PrTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 4 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18-42 years of age.
Who cannot join
- • Unable/unwilling to commit to participating in 1x per day treatments for 6 consecutive weeks
- Outside of the age range of 18-42
- Currently undergoing hormone therapy
- History of blood clotting disorder
- History of open skull traumatic brain injury
- History of clinically significant seizure disorder
Show all 47Show fewer
- History of clinically significant manic episodes
- Diagnosed with Diabetes Mellitus
- Individuals with a clinically defined neurological disorder including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Cerebral aneurysm
- Has participated in any type of rTMS treatment within 3 months prior to the screening visit
- Currently receiving antipsychotic or anticonvulsant medication treatment
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
- Clinically significant medical illness, including any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning
- History of psychosis
- History of migraines
- Current thoughts of suicidal ideation or self-harm
- Substance use disorder within the past six months
- Those pregnant or actively trying to become pregnant
- Intake of one or a combination of the following drugs forms a 'Strong Potential Hazard' for application of rTMS due to their significant seizure threshold lowering potential:
- Imipramine
- Amitriptyline
- Doxepine
- Nortriptyline
- Maprotiline
- Chlorpromazine
- Clozapine
- Foscarnet
- Ganciclovir
- Ritonavir
- Amphetamines
- Cocaine (MDMA, ecstasy)
- Phencyclidine (PCP, angel's dust)
- Ketamine
- Gamma-hydroxybutyrate (GHB)
- Alcohol
- Theophylline
- Note: Being on one of these medications or substances would not automatically exclude a participant from study participation. The risk is dependent on the patient's past medical history, drug dose, speed of dose increase (or decrease), history of recent medication changes or duration of treatment, and combination with other CNS active drugs. Considering all the variables and keeping participant safety in mind, if a potential participant is on any of the above medication, the participant will be carefully evaluated and a justification for the decision to include them in the study will be documented by the medically responsible physician.
- Recent withdrawal from one of the following drugs forms a 'Strong Relative Hazard' for application of rTMS due to the resulting significant seizure threshold lowering potential:
- Alcohol
- Barbiturates
- Benzodiazepines
- Meprobamate
- Chloral hydrate
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26505
About this study
Official title: Effects of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) on Human Performance and Sleep Quality
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.
Read the detailed description
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.
- Conditions
- Sleep Quality, Cognition Improvement
- Being tested
- PrTMS, Sham
- Keywords
- PrTMS, EEG, Sleep, Cogniton
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrTMSDevice
Each participant will receive a personalized rTMS treatment based on their individual alpha frequency.
ShamDevice
Using a sham coil that looks and sounds like an actual TMS coil, each participant will receive sham rTMS treatments.
| Study group | Role | What they receive |
|---|---|---|
| Active PrTMS | Active comparator | Participants will receive PrTMS five days a week for six weeks. Receives: Device: PrTMS |
| Sham | Sham comparator | Participants will receive sham treatment five days a week for six weeks. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Daily from baseline through study completion at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start4 Dec 2023
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Why it stopped: Study never commenced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to an active or sham intervention group. Each participant will complete 30 PrTMS or sham sessions. Through the course of the 6-week study, participants will be asked to wear a lab-provided sleep tracking ring (Oura). Each participant, regardless of group, will complete daily and weekly surveys and assessments including a qEEG and cognitive assessments. At the intake, midpoint, and exit, a battery of surveys will be administered as well.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Finomore, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353244
- Sponsor's protocol ID
- 2111477106
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) on Human Performance and Sleep Quality
- ClinicalTrials.gov ID
- NCT05353244
- Acronym / sponsor ID
- 2111477106
- Conditions
- Sleep Quality, Cognition Improvement
- Keywords
- PrTMS, EEG, Sleep, Cogniton
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never commenced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an active or sham intervention group. Each participant will complete 30 PrTMS or sham sessions. Through the course of the 6-week study, participants will be asked to wear a lab-provided sleep tracking ring (Oura). Each participant, regardless of group, will complete daily and weekly surveys and assessments including a qEEG and cognitive assessments. At the intake, midpoint, and exit, a battery of surveys will be administered as well.
| Arm | Type | Receives |
|---|---|---|
| Active PrTMS | Active comparator | Device: PrTMSParticipants will receive PrTMS five days a week for six weeks. |
| Sham | Sham comparator | Device: ShamParticipants will receive sham treatment five days a week for six weeks. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female between 18-42 years of age.
Key exclusion criteria (47 listed)
- • Unable/unwilling to commit to participating in 1x per day treatments for 6 consecutive weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrTMSEach participant will receive a personalized rTMS treatment based on their individual alpha frequency. | Device | Active PrTMS |
| ShamUsing a sham coil that looks and sounds like an actual TMS coil, each participant will receive sham rTMS treatments. | Device | Sham |
Primary outcome
Change in Nocturnal Heart Rate as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Heart rate variability (as measured by variance in time between heart beats) will be quantified throughout the night via the OURA ring.
Change in Sleep Latency as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Sleep onset latency will be quantified throughout the night via the OURA ring.
Change in Sleep Score as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Total sleep score will be quantified throughout the night via the OURA ring.
Change in Total Sleep Time as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Time of sleep will be quantified throughout the night via the OURA ring.
Change in Sleep Efficiency as measured by OURA Ring
Time frame: Daily from baseline through study completion at 6 weeks
Sleep efficiency will be quantified throughout the night via the OURA ring.
Change in Sleep Quality as measured via Questionnaire
Time frame: Daily from baseline through study completion at 6 weeks
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.
Change in Recovery as measured via Questionnaire
Time frame: Daily from baseline through study completion at 6 weeks
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.
Change in Stress as measured via Questionnaire
Time frame: Daily from baseline through study completion at 6 weeks
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.
Change in Sustained Attention and Reaction Time
Time frame: Daily from baseline through study completion at 6 weeks
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.
Change in Subjective Sleep Quality measured via Questionnaire
Time frame: Weekly from baseline through study completion at 6 weeks.
Participants will complete the Sleep Condition Indicator weekly. Scores range from 0-32. Higher scores indicate better sleep.
Change in Subjective Attention measured via Questionnaire
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
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.
Change in Subjective Anxiety measured via Questionnaire
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
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.
Change in Subjective Depression measured via Hamilton Depression Rating Scale
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
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.
Change in Subjective Depression measured via Patient Health Questionnaire
Time frame: Intake (week 1), Mid-point (week 3) and exit (week 6)
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.
Change in Subjective Anxiety measured via Questionnaire
Time frame: Weekly from baseline through study completion at 6 weeks
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
Change in Mood as Indicated via Questionnaire
Time frame: Daily from baseline through study completion at 6 weeks
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrTMS in people with Sleep Quality and Cognition Improvement, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nocturnal Heart Rate as measured by OURA Ring (time frame: Daily from baseline through study completion at 6 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024; AzTrials last refreshed its copy on 29 Oct 2026.