RugbyCERVITRAINNCT06545006
Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine
A study testing isometric contractions, stroboscopic glasses and Quick Release in people with Rugby and Craniocerebral Trauma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The goal of this clinical trial is to learn if Quick Release dynamic strengthening of the cervical spine extensor muscles' reflex could improve dynamic stabilisation capacities of the cervical spine by reducing muscle activation delay in amateurs rugby players. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rugby, Craniocerebral Trauma, Cervical Spine Injury
- What is being tested?
- isometric contractions, stroboscopic glasses and Quick Release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2024to 8 Nov 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Possess a valid rugby practice licence
- Non Inclusion Criteria :
- History of serious cervical trauma during his career with : Need for surgery (in case of arthrodesis at 2 or more levels) and/or Persistent after-effects (sensory or motor), any cervicobrachial symptomatology.
- History of epileptic disease
- Any concussion less than one month old
Show all 10Show fewer
- Population with special legal protection: Pregnant or breast-feeding woman (L. 1121-5), subject deprived of liberty (art.L. 1121-6), minors (L.1121-7), patient unable to give consent (L1121-8), protected adults (L. 1121-8), not affiliated to a social security scheme (L1121-8-1), vulnerable persons (L.1122-2), exclusion period (Article L1121-12).
- Refusal of consent after information
- Participant not fluent in French and without a support person able to read.
- People who practice other contact sports.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if Quick Release dynamic strengthening of the cervical spine extensor muscles' reflex could improve dynamic stabilisation capacities of the cervical spine by reducing muscle activation delay in amateurs rugby players. The main questions it aims to answer are described as follows:
The primary outcome measure is the comparison between the intervention and control groups of the variation in activation delay of the cervical spine extensor muscles in milliseconds (ms) between the beginning and the end of the strengthening program. The activation delay in milliseconds corresponds to the time between the onset of impact application on the head and the onset of reactive muscle force production measured by the Cervistab© ergometer.
Read more
The secondary outcomes are also a comparison between the two groups of the variations from the beginning to the end of the strengthening program for the followings parameters, measured during with the Cervistab© machine:
- Reflex Force Production Rate (N/ms): slope of the force/time graph.
- Maximum Reactive Force (N): maximum force value produced within 300 ms following impact.
- In both intervention groups: measurement of the variation in head displacement (in mm) during quick release strengthening protocol.
- In each subgroup, 10 participants will be equipped with Instrumented Mouthguards. Researchers will compare the variation in workload measured by these mouthguards during Cervistab evaluations conducted before and after the training protocol.
Researchers will compare the intervention group to a distractor (control) arm to see if our training protocol has an impact on the activation delay.
Read the detailed description
Rugby authorities are seeking preventive measures to reduce cranio-cervical injuries. Literature suggests that early and strong contraction of cervical spine muscles could decrease this risk. The Quick Release principle, using maximal isometric contractions and non-impact disturbances, might improve the dynamic stabilization of the cervical spine. No study has yet evaluated the effect of muscle strengthening programs on this stabilization.
It is hypothesized that specific training of the cervical spine extensor muscles could reduce activation delay and increase reflexive force.
This study is a single-centre, controlled, randomised, and stratified based on activation delay.
It is an open study with blind evaluation. Randomization will be stratified based on the activation delay of the cervical spine extensor muscles into two sub-groups (slow and fast), measured during the Cervistab© test at the inclusion visit.
Researchers propose an open-label study with blind evaluation: The principal investigator, who will conduct the pre- and post-training protocol tests, will not be involved in the training protocol (conducted by the associated investigator) and will therefore not know which program the tested subject completed.
Both groups will undergo a foundational cervical muscle strengthening regimen, which includes classic isometric contraction strengthening (duration = 20 minutes) at the beginning of their training session.
The second part of each training session will depend on the group to which the participants have been randomised (also 20 minutes):
- Either 20 minutes of dynamic strengthening through Quick Release (tested arm)
- Or 20 minutes of decision-making aid with Stroboscopic Glasses (control arm with distractor)
Both groups will do 10 trainings of 40 minutes dispatched on one month.
Cervistab ergometer is a machine developped by the main investigator and engineers that records force (in newton) as a function of time. It delivers impacts over the head of the subject. Each subject puts himself in "scrum" position and take small impacts over the head and the Cervistab ergometer can measure the reflex force production rate after the activation delay.
Distractor arm : The comparison group will have to do useful tasks for their rugby practice that does not have an impact on the primary outcome. Here, researchers will ask the comparison group to use stroboscopic glasses to train their decision skills in catching and throwing rugby balls. The stroboscopic glasses switch from bright to dark at a certain frequency and hence, reduce the amount of visual information.
- Conditions
- Rugby, Craniocerebral Trauma, Cervical Spine Injury
- Being tested
- isometric contractions, stroboscopic glasses, Quick Release
- Keywords
- Cervical Muscle, Dynamic Strengthening, Stabilization, Cervical Spine, Head Impact, Rugby
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isometric contractionsOther
Participants will perform 20 minutes of isometric contractions in different positions, with contraction durations of 10 seconds and a number of repetitions between 4 and 10, depending on their progress in the training program.
stroboscopic glassesOther
This training involves performing skill exercises with a rugby ball while wearing stroboscopic glasses. The glasses have alternating opaque and clear sections, causing multiple and/or fragmented vision.
The goal is to improve the processing of visual information at the level of higher functions. This aids in decision-making. It does not involve the same structures and functions implicated in reflexive muscle recruitment strategies as the Quick Release, so it should not be a confounding factor. However, it provides a beneficial, stimulating, and enjoyable training session, increasing subject adherence as they work on a skill useful in their sport.
Quick ReleaseOther
The distance (in mm) of the anterior head translation will be measured using a linear displacement sensor. The subject will be instructed to recruit their extensor muscles as quickly and as strongly as possible to minimise the head displacement distance. They will be aware of their score after each repetition (real-time feedback).
Subjects must react to a rapid forward displacement of the cervical spine, without impact. To generate this forward displacement without impact, subjects are positioned with support in front of the forehead, holding their head and neck. The subject must exert an isometric flexion effort against this frontal support (energy storage), with the intensity set by the examiner based on the Maximum Isometric Force measured during a prior maximal isometric test. The frontal resistance will suddenly release, and the head displacement in the sagittal plane will be measured until the recruitment of the cervical spine extensor muscles stops this displacement
| Study group | Role | What they receive |
|---|---|---|
| Quick Release Strengthening | Experimental | The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of Quick release strengthening Receives: Other: isometric contractions; Other: Quick Release |
| Stroboscopic Glasses Tasks | Sham comparator | The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of exercises with a rugby ball while wearing stroboscopic glasses. Receives: Other: isometric contractions; Other: stroboscopic glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the activation delay
the time between the onset of impact application on the head and the onset of reactive muscle force production (in miliseconds)
comparison between the intervention and control groups of the variation in muscle activation delay of the cervical spine extensors (in ms) between the start and the end of the strengthening program. The activation delay in ms corresponds to the time between the start of the application of impact to the head and the start of production of reactive muscle force during the test on the Cervistab© ergometer.
Measured: Baseline and at end (week 6)
Secondary outcomes (3)
Rate of Reflex Force Production
Comparison between the 2 groups of the variations between the beginning and the end of the reinforcement program, of the following parameter : slope of the force/time graph in newton per miliseconds
Measured: Baseline and at end (week 6)
Maximum Reactive Force
Comparison between the 2 groups of the variations between the beginning and the end of the reinforcement program, of the following parameter : maximum force value produced within 300 ms following impact in newton
Measured: Baseline and at end (week 6)
Workload
In each subgroup of 10 participants fitted with instrumented mouthguards, the variation in workload measured by these mouthguards will be compared during Cervistab assessments carried out before and after the training protocol (in G).
Measured: Baseline and at end (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start19 Aug 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RugbyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, controlled, randomized, stratified on time to activation of cervical spine extensor muscles, open-label study with blinded evaluation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Marc Julia, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545006
- Sponsor's protocol ID
- RECHMPL24_0006
- Acronym
- CERVITRAIN
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers will make available any informations useful for reviewers or other researchers interested by doing complementary studies based on our works
Publications
Bohu Y, Julia M, Bagate C, Peyrin JC, Colonna JP, Thoreux P, Pascal-Moussellard H. Declining incidence of catastrophic cervical spine injuries in French rugby: 1996-2006. Am J Sports Med. 2009 Feb;37(2):319-23. doi: 10.1177/0363546508325926.
PubMed 19182111Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
PubMed 24488820Pedersen MT, Essendrop M, Skotte JH, Jorgensen K, Fallentin N. Training can modify back muscle response to sudden trunk loading. Eur Spine J. 2004 Oct;13(6):548-52. doi: 10.1007/s00586-004-0679-3. Epub 2004 Feb 25.
PubMed 14986074Garrett JM, Mastrorocco M, Peek K, van den Hoek DJ, McGuckian TB. The Relationship Between Neck Strength and Sports-Related Concussion in Team Sports: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2023 Oct;53(10):585-593. doi: 10.2519/jospt.2023.11727.
PubMed 37428807Tognella F, Mainar A, Vanhoutte C, Goubel F. A mechanical device for studying mechanical properties of human muscles in vivo. J Biomech. 1997 Oct;30(10):1077-80. doi: 10.1016/s0021-9290(97)00067-5.
PubMed 9391877Daneshvar DH, Goldstein LE, Kiernan PT, Stein TD, McKee AC. Post-traumatic neurodegeneration and chronic traumatic encephalopathy. Mol Cell Neurosci. 2015 May;66(Pt B):81-90. doi: 10.1016/j.mcn.2015.03.007. Epub 2015 Mar 7.
PubMed 25758552
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine
- ClinicalTrials.gov ID
- NCT06545006
- Acronym / sponsor ID
- CERVITRAIN / RECHMPL24_0006
- Conditions
- Rugby, Craniocerebral Trauma, Cervical Spine Injury
- Keywords
- Cervical Muscle, Dynamic Strengthening, Stabilization, Cervical Spine, Head Impact, Rugby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 9 Aug 2024 (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 goal of this clinical trial is to learn if Quick Release dynamic strengthening of the cervical spine extensor muscles' reflex could improve dynamic stabilisation capacities of the cervical spine by reducing muscle activation delay in amateurs rugby players. The main questions it aims to answer are described as follows:
The primary outcome measure is the comparison between the intervention and control groups of the variation in activation delay of the cervical spine extensor muscles in milliseconds (ms) between the beginning and the end of the strengthening program. The activation delay in milliseconds corresponds to the time between the onset of impact application on the head and the onset of reactive muscle force production measured by the Cervistab© ergometer.
The secondary outcomes are also a comparison between the two groups of the variations from the beginning to the end of the strengthening program for the followings parameters, measured during with the Cervistab© machine:
- Reflex Force Production Rate (N/ms): slope of the force/time graph.
- Maximum Reactive Force (N): maximum force value produced within 300 ms following impact.
- In both intervention groups: measurement of the variation in head displacement (in mm) during quick release strengthening protocol.
- In each subgroup, 10 participants will be equipped with Instrumented Mouthguards. Researchers will compare the variation in workload measured by these mouthguards during Cervistab evaluations conducted before and after the training protocol.
Researchers will compare the intervention group to a distractor (control) arm to see if our training protocol has an impact on the activation delay.
Detailed description
Rugby authorities are seeking preventive measures to reduce cranio-cervical injuries. Literature suggests that early and strong contraction of cervical spine muscles could decrease this risk. The Quick Release principle, using maximal isometric contractions and non-impact disturbances, might improve the dynamic stabilization of the cervical spine. No study has yet evaluated the effect of muscle strengthening programs on this stabilization.
It is hypothesized that specific training of the cervical spine extensor muscles could reduce activation delay and increase reflexive force.
This study is a single-centre, controlled, randomised, and stratified based on activation delay.
It is an open study with blind evaluation. Randomization will be stratified based on the activation delay of the cervical spine extensor muscles into two sub-groups (slow and fast), measured during the Cervistab© test at the inclusion visit.
Researchers propose an open-label study with blind evaluation: The principal investigator, who will conduct the pre- and post-training protocol tests, will not be involved in the training protocol (conducted by the associated investigator) and will therefore not know which program the tested subject completed.
Both groups will undergo a foundational cervical muscle strengthening regimen, which includes classic isometric contraction strengthening (duration = 20 minutes) at the beginning of their training session.
The second part of each training session will depend on the group to which the participants have been randomised (also 20 minutes):
- Either 20 minutes of dynamic strengthening through Quick Release (tested arm)
- Or 20 minutes of decision-making aid with Stroboscopic Glasses (control arm with distractor)
Both groups will do 10 trainings of 40 minutes dispatched on one month.
Cervistab ergometer is a machine developped by the main investigator and engineers that records force (in newton) as a function of time. It delivers impacts over the head of the subject. Each subject puts himself in "scrum" position and take small impacts over the head and the Cervistab ergometer can measure the reflex force production rate after the activation delay.
Distractor arm : The comparison group will have to do useful tasks for their rugby practice that does not have an impact on the primary outcome. Here, researchers will ask the comparison group to use stroboscopic glasses to train their decision skills in catching and throwing rugby balls. The stroboscopic glasses switch from bright to dark at a certain frequency and hence, reduce the amount of visual information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single-center, controlled, randomized, stratified on time to activation of cervical spine extensor muscles, open-label study with blinded evaluation.
| Arm | Type | Receives |
|---|---|---|
| Quick Release Strengthening | Experimental | Other: isometric contractions, Other: Quick ReleaseThe rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of Quick release strengthening |
| Stroboscopic Glasses Tasks | Sham comparator | Other: isometric contractions, Other: stroboscopic glassesThe rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of exercises with a rugby ball while wearing stroboscopic glasses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 or older
- Possess a valid rugby practice licence
- History of serious cervical trauma during his career with : Need for surgery (in case of arthrodesis at 2 or more levels) and/or Persistent after-effects (sensory or motor), any cervicobrachial symptomatology.
- History of epileptic disease
- Any concussion less than one month old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| isometric contractionsParticipants will perform 20 minutes of isometric contractions in different positions, with contraction durations of 10 seconds and a number of repetitions between 4 and 10, depending on their progress in the training program. | Other | Quick Release Strengthening, Stroboscopic Glasses Tasks |
| stroboscopic glassesThis training involves performing skill exercises with a rugby ball while wearing stroboscopic glasses. The glasses have alternating opaque and clear sections, causing multiple and/or fragmented vision. The goal is to improve the processing of visual information at the level of higher functions. This aids in decision-making. It does not involve the same structures and functions implicated in reflexive muscle recruitment strategies as the Quick Release, so it should not be a confounding factor. However, it provides a beneficial, stimulating, and enjoyable training session, increasing subject adherence as they work on a skill useful in their sport. | Other | Stroboscopic Glasses Tasks |
| Quick ReleaseThe distance (in mm) of the anterior head translation will be measured using a linear displacement sensor. The subject will be instructed to recruit their extensor muscles as quickly and as strongly as possible to minimise the head displacement distance. They will be aware of their score after each repetition (real-time feedback). Subjects must react to a rapid forward displacement of the cervical spine, without impact. To generate this forward displacement without impact, subjects are positioned with support in front of the forehead, holding their head and neck. The subject must exert an isometric flexion effort against this frontal support (energy storage), with the intensity set by the examiner based on the Maximum Isometric Force measured during a prior maximal isometric test. The frontal resistance will suddenly release, and the head displacement in the sagittal plane will be measured until the recruitment of the cervical spine extensor muscles stops this displacement | Other | Quick Release Strengthening |
Primary outcome
Comparison of the activation delay
Time frame: Baseline and at end (week 6)
the time between the onset of impact application on the head and the onset of reactive muscle force production (in miliseconds) comparison between the intervention and control groups of the variation in muscle activation delay of the cervical spine extensors (in ms) between the start and the end of the strengthening program. The activation delay in ms corresponds to the time between the start of the application of impact to the head and the start of production of reactive muscle force during the test on the Cervistab© ergometer.
3 secondary outcomes
Rate of Reflex Force Production
Time frame: Baseline and at end (week 6)
Maximum Reactive Force
Time frame: Baseline and at end (week 6)
Workload
Time frame: Baseline and at end (week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 19182111Bohu Y, Julia M, Bagate C, Peyrin JC, Colonna JP, Thoreux P, Pascal-Moussellard H. Declining incidence of catastrophic cervical spine injuries in French rugby: 1996-2006. Am J Sports Med. 2009 Feb;37(2):319-23. doi: 10.1177/0363546508325926.
- Results publication: PubMed 24488820Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
- Results publication: PubMed 14986074Pedersen MT, Essendrop M, Skotte JH, Jorgensen K, Fallentin N. Training can modify back muscle response to sudden trunk loading. Eur Spine J. 2004 Oct;13(6):548-52. doi: 10.1007/s00586-004-0679-3. Epub 2004 Feb 25.
- Results publication: PubMed 37428807Garrett JM, Mastrorocco M, Peek K, van den Hoek DJ, McGuckian TB. The Relationship Between Neck Strength and Sports-Related Concussion in Team Sports: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2023 Oct;53(10):585-593. doi: 10.2519/jospt.2023.11727.
- Results publication: PubMed 9391877Tognella F, Mainar A, Vanhoutte C, Goubel F. A mechanical device for studying mechanical properties of human muscles in vivo. J Biomech. 1997 Oct;30(10):1077-80. doi: 10.1016/s0021-9290(97)00067-5.
- Results publication: PubMed 25758552Daneshvar DH, Goldstein LE, Kiernan PT, Stein TD, McKee AC. Post-traumatic neurodegeneration and chronic traumatic encephalopathy. Mol Cell Neurosci. 2015 May;66(Pt B):81-90. doi: 10.1016/j.mcn.2015.03.007. Epub 2015 Mar 7.
- Individual participant dataSharing planned: Undecided. Researchers will make available any informations useful for reviewers or other researchers interested by doing complementary studies based on our works
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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.
Marc Julia, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isometric contractions, stroboscopic glasses and Quick Release in people with Rugby and Craniocerebral Trauma, run by University Hospital, Montpellier at 1 site in France.
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 10 inclusion and 0 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: finished, as of the sponsor's last update on 15 Jun 2026. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the activation delay (time frame: Baseline and at end (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545006, which also lists 6 linked publications.
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 15 Jun 2026.