Brain InjuriesNCT05690919
Examining the Experiences of Brain Injury Patients in Medical Trials
An observational study of Brain Injuries, run by Power Life Sciences Inc..
Trial summary
Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Brain injury patients who are actively considering enrolling in an intensive clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Patient has been diagnosed with brain injury
- Patient is 18 years old
- Patient has self-identified as planning to enroll in an interventional clinical trial
Who cannot join
- Patient does not understand, sign, and return consent form
- Patient is pregnant
- Inability to perform regular electronic reporting
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Study Analyzing Brain Injury Patients Experience Patterns in Medical Trials
Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.
Brain injury clinical trial patients help us identify these factors by sharing trial experiences during the course of the interventional medical study.
This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future brain injury patients who are considering participating in a medical study.
- Conditions
- Brain Injuries
- Keywords
- Brain Injuries
- Medical subject headings
- Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in a brain injury clinical trial.
Measured: 3 months
Rate of patients who remain in brain injury 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 posted19 Jan 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (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 Brain InjuriesStudies 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
- NCT05690919
- Sponsor's protocol ID
- 84028751
- Status last verified
- Jun 2023
- First submitted
- 10 Jan 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics. 2010 Jan;7(1):115-26. doi: 10.1016/j.nurt.2009.10.022.
PubMed 20129503Wat R, Mammi M, Paredes J, Haines J, Alasmari M, Liew A, Lu VM, Arnaout O, Smith TR, Gormley WB, Aglio LS, Mekary RA, Zaidi H. The Effectiveness of Antiepileptic Medications as Prophylaxis of Early Seizure in Patients with Traumatic Brain Injury Compared with Placebo or No Treatment: A Systematic Review and Meta-Analysis. World Neurosurg. 2019 Feb;122:433-440. doi: 10.1016/j.wneu.2018.11.076. Epub 2018 Nov 20.
PubMed 30465951Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8.
PubMed 33161752
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Analyzing Brain Injury Patients Experience Patterns in Medical Trials
- ClinicalTrials.gov ID
- NCT05690919
- Acronym / sponsor ID
- 84028751
- Conditions
- Brain Injuries
- Keywords
- Brain Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Jan 2023 (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.
Historically, participation in clinical trials has been skewed towards certain groups. However, research on the factors that influence participation, both positive and negative, is limited.
Brain injury clinical trial patients help us identify these factors by sharing trial experiences during the course of the interventional medical study.
This study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. The collected data will then be used to benefit future brain injury patients who are considering participating in a medical study.
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
- Brain injury patients who are actively considering enrolling in an intensive clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Patient has been diagnosed with brain injury
- Patient is 18 years old
- Patient has self-identified as planning to enroll in an interventional clinical trial
Key exclusion criteria (3 listed)
- Patient does not understand, sign, and return consent form
- Patient is pregnant
- Inability to perform regular electronic reporting
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 patients who decide to enroll in a brain injury clinical trial.
Time frame: 3 months
Rate of patients who remain in brain injury clinical trial to trial completion.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Background: PubMed 20129503Maas AI, Roozenbeek B, Manley GT. Clinical trials in traumatic brain injury: past experience and current developments. Neurotherapeutics. 2010 Jan;7(1):115-26. doi: 10.1016/j.nurt.2009.10.022.
- Background: PubMed 30465951Wat R, Mammi M, Paredes J, Haines J, Alasmari M, Liew A, Lu VM, Arnaout O, Smith TR, Gormley WB, Aglio LS, Mekary RA, Zaidi H. The Effectiveness of Antiepileptic Medications as Prophylaxis of Early Seizure in Patients with Traumatic Brain Injury Compared with Placebo or No Treatment: A Systematic Review and Meta-Analysis. World Neurosurg. 2019 Feb;122:433-440. doi: 10.1016/j.wneu.2018.11.076. Epub 2018 Nov 20.
- Background: PubMed 33161752Kjeldsen SS, Brodal L, Brunner I. Activity and rest in patients with severe acquired brain injury: an observational study. Disabil Rehabil. 2022 Jun;44(12):2744-2751. doi: 10.1080/09638288.2020.1844317. Epub 2020 Nov 8.
- 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. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Power Life Sciences Inc..
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: status not confirmed, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, 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 patients who decide to enroll in a brain injury clinical trial. (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 NCT05690919, 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 12 Jun 2023.