An Early Phase 1 interventional study of OSC+ and OSC- in Traumatic Brain Injury, sponsored by Brigham Young University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Brigham Young University · Early Phase 1, Interventional, and Treatment
Among 907 studies in Brain Injuries, Traumatic with a site in United States — 210 open to participants now, 247 under way, 5 of them phase 3. Brain Injuries, Traumatic · United States.
Among the 907 studies in Brain Injuries, Traumatic with a site in United States, this one is the 315th largest by planned enrollment of the 648 interventional ones that give a count, is one of 42 that started in 2023, is one of 46 in phase 1, reaches primary completion later than 9 of the 246 other live ones, and was the 732nd registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
Browse Brain Injuries, Traumatic studies →210 of the 907 studies in Brain Injuries, Traumatic with a site in United States are open now. Recruiting first, the newest first:
Andrew Mayer · Sites in United States
Columbia University · Sites in United States
Columbia University · Sites in United States, Brazil, Canada and 2 more countries
University of Michigan · Sites in United States
University of Michigan · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
907 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 65 · Phase 2 110 · Phase 3 39 · Phase 4 28
First in 1996; this study’s year is marked. 42 started in 2023.
This study's planned enrollment of 50 is close to the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Median enrollment 50 across the 648 interventional studies, 120 across the 257 observational. Of the 553 that completed or were terminated, 182 (33%) have results posted.
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101 of 907 have an industry lead sponsor. The 10 most frequent:
Brigham Young University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Brigham Young University has 1 study filed under Brain Injuries, Traumatic — fewer than ten, so there is no comparison to draw.
82 of the studies in Brain Injuries, Traumatic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06368648CoMind Technologies LimitedCoMind Early Feasibility Study | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT07733284Kessler FoundationHome-Based Walking for Thinking Skills in Persons With TBI | 2026-12 |
| NCT06228391Minneapolis Veterans Affairs Medical CenterKetamine Treatment for PTSD and MDD in TBI | 2026-12 |
| NCT05702138Craig HospitalHigh Intensity Step Training After Traumatic Brain Injury | 2026-12 |
Among the 907 studies in Brain Injuries, Traumatic with a site in United States, from their registry updates:
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Individuals with mild traumatic brain injury will be randomly assigned to an active heart rate variability biofeedback condition and a sham condition. The investigators will use a randomized pre-post design that will consist of two data collection phases and a 5-week treatment condition. The heart rate variability biofeedback active condition is designed to increase heart rate oscillations (Osc+ condition) consistent with current best practices, while the sham control heart rate variability biofeedback condition is designed to decrease heart rate oscillations (Osc- condition).
There are two primary aims of the study: (1) examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback; (2) to test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback. Regarding the first primary aim, the investigators hypothesize that heart rate variability will be higher in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to those in the control/sham condition where the investigators do not expect such improvement pre- to post-testing. For the second aim, consistent with previous work, the investigators hypothesize that heart rate variability recovery following a stressor will be faster in individuals with mild traumatic brain injury following heart rate variability biofeedback compared to a sham control condition. There are three secondary aims for this study: (1) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in physical symptoms common after head injury (i.e., headaches, dizziness, sleep disturbance); (2) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in emotional functioning (i.e., life satisfaction, anxiety symptoms, depression symptoms); and (3) to evaluate whether improvements in heart rate variability in individuals with mild traumatic brain injury following heart rate variability biofeedback are associated with improvements in cognitive functioning (i.e., attention, inhibitory control).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twenty-five participants will complete five weeks of heart rate variability biofeedback using emWave software (HeartMath®Institute, 2020). Participants will receive a weekly 30-minute heart rate variability biofeedback session for five weeks at the University Parkway Center, Brigham Young University. The heart rate variability biofeedback protocol will be based on Lehrer et al., 2013 and Yoo et al., 2022. This format will aid participants in implementing and learning breathing and heart rate variability biofeedback skills (Lehrer et al., 2020). All participants will wear an ear sensor to measure their pulse. The heart rate variability biofeedback will focus on autonomic balance through slow breathing at a resonance frequency of approximately 6 breathes per minute. The best approximate breathing pace for resonance frequency will be estimated and participant's resonance frequency will be provided and used for their homework and subsequent training sessions.
Behavioral: OSC+
Twenty-five participants will complete five weeks of Osc-. Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. During the weekly session, participants will also be wearing an earlobe monitor with HeartMath. Participants will be administered the Scale of Positive and Negative Experience at the beginning of each session to assess for mood. Participants will also be administered the 3-item Rivermead Post Concussion Symptoms Questionnaire at the beginning of each session. Participants will be instructed that the purpose of this portion of the study is to decrease their breathing oscillations. A program was designed by Yoo and colleagues (2022) that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breath in a pattern that elicits less variability (i.e., less oscillations).
Behavioral: OSC-
The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.
During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.
Stress Recovery
Test whether heart rate variability recovery following a stressor improves in individuals with mild traumatic brain injury following heart rate variability biofeedback
Time frame: Through study completion, an average of 7 weeks
Resting HRV
Examine whether heart rate variability increases at rest in individuals with mild traumatic brain injury from pre-treatment to post-treatment following heart rate variability biofeedback
Time frame: Through study completion, an average of 7 weeks
Physical Symptoms
The Rivermead Post Concussion Symptoms Questionnaire is a 16-item self-report measure of the severity of post-concussive symptoms following traumatic brain injury. The scale includes three categories of behavioral, physical, and cognitive symptoms, where participants are asked to rate the degree to which they experience 16 concussive symptoms in comparison to pre-injury symptoms within the past 24 hours. The items are rated on a 5-point scale from 0 (not experienced at all) to 4 (a severe problem). The RPQ-13 and RPQ-3 have good internal consistency and good test-retest reliability (0.89 and 0.72, respectively).
Time frame: Through study completion, an average of 7 weeks
Scale of Positive and Negative Experience
The Scale of Positive and Negative Experience is a 12-item scale that assesses participant experiences in various states (e.g., sad, happy, afraid) on a 5-point scale from 1 (never) to 5 (always).
Time frame: Through study completion, an average of 7 weeks
Depression Anxiety Stress Scales
The Depression Anxiety Stress Scales is a three-part self-report measure consisting of 42 items related to negative emotional states of tension/stress, anxiety, and depression. Each scale contains subscales of 2-4 items totaling 14 items. Each scale contains a four-point scale of severity and frequency to be rated on experiences over the past week.
Time frame: Through study completion, an average of 7 weeks
Satisfaction with Life Scale
The Satisfaction with Life Scale assesses judgments of one's life satisfaction using a 5-item scale. Scores are reported on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). While the scale does not assess life satisfaction across multiple domains, it quantifies a global measure of subjective well-being. Total scores range from 7 to 35, with higher scores indicating higher satisfaction.
Time frame: Through study completion, an average of 7 weeks
Cognitive Functioning
The NIH Toolbox for the Assessment of Neurological Behavior and Function Cognition Battery is approximately 30 minutes and consists of seven measures, including Picture Vocabulary, Oral Reading Recognition, Picture Sequence Memory, Dimensional Change Card Sort Test, List Sorting Working Memory, Flanker Inhibitory Control and Attention Test, and Pattern Comparison Processing Speed. The NIHTB-CB consists of two composite scores: a Crystallized Cognition Composite Score, providing a pre-injury estimate of overall cognitive ability, which is a combined score of Picture Vocabulary and Oral Reading Recognition; and a Fluid Cognition Composite Score, which is a combined score of Picture Sequence Memory, Dimensional Change Card Sort Test, List Sorting Working Memory, Flanker Inhibitory Control and Attention Test, and Pattern Comparison Processing Speed. The age-adjusted scaled score has a mean of 100 and a standard deviation of 15.
Time frame: Through study completion, an average of 7 weeks
Plan to share: Yes — Study protocol, materials, and analysis plans are already posted on the Open Science Framework (https://osf.io/5gwpk). Actual study data (de-identified) will be made available, along with analysis codes, once the study has been complete and published.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Once data collection and data analysis has been completed and published in a scientific journal, the study data (de-identified) will either be posted on an open science website, such as the Open Science Framework, or will be given to other researchers upon request.
Data sharing details ↗ · osf.io
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Apr 2024, 14 months after the start.
Of 27 phase 1 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 66. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
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Brigham Young University