TBINCT06288698
Understanding Patient Engagement Trends in TBI Clinical Research
An observational study of TBI, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with TBI who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Participant must be 18 years of age or older
- Confirmed diagnosis of TBI
Who cannot join
- Enrolled in another research study
- Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Analyzing Enrolment and Engagement Trends in Individuals Confronting TBI: Insights From TBI Clinical Trials
Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.
The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.
- Conditions
- TBI
- Keywords
- TBI
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of TBI patients who decide to enroll in a clinical research
Measured: 3 months
Rate of TBI patients who remain in clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TBIStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288698
- Sponsor's protocol ID
- 53955721
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perry DC, Sturm VE, Peterson MJ, Pieper CF, Bullock T, Boeve BF, Miller BL, Guskiewicz KM, Berger MS, Kramer JH, Welsh-Bohmer KA. Association of traumatic brain injury with subsequent neurological and psychiatric disease: a meta-analysis. J Neurosurg. 2016 Feb;124(2):511-26. doi: 10.3171/2015.2.JNS14503. Epub 2015 Aug 28.
PubMed 26315003Kaur P, Sharma S. Recent Advances in Pathophysiology of Traumatic Brain Injury. Curr Neuropharmacol. 2018;16(8):1224-1238. doi: 10.2174/1570159X15666170613083606.
PubMed 28606040VanderVeen JD. TBI as a Risk Factor for Substance Use Behaviors: A Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1198-1209. doi: 10.1016/j.apmr.2020.10.112. Epub 2020 Nov 2.
PubMed 33152264
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Enrolment and Engagement Trends in Individuals Confronting TBI: Insights From TBI Clinical Trials
- ClinicalTrials.gov ID
- NCT06288698
- Acronym / sponsor ID
- 53955721
- Conditions
- TBI
- Keywords
- TBI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Mar 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.
Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.
The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TBI who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Participant must be 18 years of age or older
- Confirmed diagnosis of TBI
Key exclusion criteria (3 listed)
- Enrolled in another research study
- Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of TBI patients who decide to enroll in a clinical research
Time frame: 3 months
Rate of TBI patients who remain in clinical trial to trial completion
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 26315003Perry DC, Sturm VE, Peterson MJ, Pieper CF, Bullock T, Boeve BF, Miller BL, Guskiewicz KM, Berger MS, Kramer JH, Welsh-Bohmer KA. Association of traumatic brain injury with subsequent neurological and psychiatric disease: a meta-analysis. J Neurosurg. 2016 Feb;124(2):511-26. doi: 10.3171/2015.2.JNS14503. Epub 2015 Aug 28.
- Background: PubMed 28606040Kaur P, Sharma S. Recent Advances in Pathophysiology of Traumatic Brain Injury. Curr Neuropharmacol. 2018;16(8):1224-1238. doi: 10.2174/1570159X15666170613083606.
- Background: PubMed 33152264VanderVeen JD. TBI as a Risk Factor for Substance Use Behaviors: A Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1198-1209. doi: 10.1016/j.apmr.2020.10.112. Epub 2020 Nov 2.
- Individual participant dataSharing planned: Undecided
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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.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI, run by Power Life Sciences Inc. 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Mar 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of TBI patients who decide to enroll in a clinical research (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT06288698, which also lists 3 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 1 Mar 2024.