Effects of PrTMS on Performance

NCT05353244 | Withdrawn FDA Device

• 1 other identifier: 2111477106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Quality; Cognition Improvement

Keywords

PrTMS; EEG; Sleep; Cogniton

Outcome Measures

Primary Outcomes (17)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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.

  Daily from baseline through study completion at 6 weeks

Study Arms (2)

Active PrTMS

ACTIVE COMPARATOR

Participants will receive PrTMS five days a week for six weeks.

Device: PrTMS

Sham

SHAM COMPARATOR

Participants will receive sham treatment five days a week for six weeks.

Device: Sham

Interventions

PrTMS DEVICE

Each participant will receive a personalized rTMS treatment based on their individual alpha frequency.

Active PrTMS

Sham DEVICE

Using a sham coil that looks and sounds like an actual TMS coil, each participant will receive sham rTMS treatments.

Sham

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18-42 years of age.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator, statisticians, and participants will be blinded to the condition (PrTMS vs Sham). Only the providers of the treatment will be aware of the treatment condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: December 4, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

US (1)