Spinal Cord InjuriesNCT05831163
Analyzing Clinical Research Participation of Patients With Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Power Life Sciences Inc..
Trial summary
The percentages of participants in clinical studies haven't always been perfectly representative of a particular group. This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 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: Patients who are actively considering involvement in an observational spinal cord injury clinical trial, but have not yet completed enrollment and registration.
Who may be able to join
- Aged ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent document.
- Diagnosis of spinal cord injury
Who cannot join
- Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
- Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Inability to provide written informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Review of Clinical Trial Experiences and Trends From Spinal Cord Injury Patients
The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.
This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future spinal cord injury research.
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a spinal cord injury clinical study.
Measured: 3 months
Number of spinal cord injury study participants who remain in clinical trial until 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 posted26 Apr 2023
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 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 Spinal Cord 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
- NCT05831163
- Sponsor's protocol ID
- 83050803
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duan R, Qu M, Yuan Y, Lin M, Liu T, Huang W, Gao J, Zhang M, Yu X. Clinical Benefit of Rehabilitation Training in Spinal Cord Injury: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2021 Mar 15;46(6):E398-E410. doi: 10.1097/BRS.0000000000003789.
PubMed 33620185Yamazaki K, Kawabori M, Seki T, Houkin K. Clinical Trials of Stem Cell Treatment for Spinal Cord Injury. Int J Mol Sci. 2020 Jun 2;21(11):3994. doi: 10.3390/ijms21113994.
PubMed 32498423Kim YH, Ha KY, Kim SI. Spinal Cord Injury and Related Clinical Trials. Clin Orthop Surg. 2017 Mar;9(1):1-9. doi: 10.4055/cios.2017.9.1.1. Epub 2017 Feb 13.
PubMed 28261421
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of Clinical Trial Experiences and Trends From Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT05831163
- Acronym / sponsor ID
- 83050803
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, spinal cord injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 26 Apr 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.
The percentages of participants in clinical studies haven't always been perfectly representative of a particular group.
This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for spinal cord injury.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future spinal cord injury research.
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 who are actively considering involvement in an observational spinal cord injury clinical trial, but have not yet completed enrollment and registration.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent document.
- Diagnosis of spinal cord injury
Key exclusion criteria (3 listed)
- Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
- Has a serious medical or psychiatric illness likely to interfere with participation in this clinical 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
Rate of patients who decide to enroll in a spinal cord injury clinical study.
Time frame: 3 months
Number of spinal cord injury study participants who remain in clinical trial until 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 26 Apr 2023.
- Background: PubMed 33620185Duan R, Qu M, Yuan Y, Lin M, Liu T, Huang W, Gao J, Zhang M, Yu X. Clinical Benefit of Rehabilitation Training in Spinal Cord Injury: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2021 Mar 15;46(6):E398-E410. doi: 10.1097/BRS.0000000000003789.
- Background: PubMed 32498423Yamazaki K, Kawabori M, Seki T, Houkin K. Clinical Trials of Stem Cell Treatment for Spinal Cord Injury. Int J Mol Sci. 2020 Jun 2;21(11):3994. doi: 10.3390/ijms21113994.
- Background: PubMed 28261421Kim YH, Ha KY, Kim SI. Spinal Cord Injury and Related Clinical Trials. Clin Orthop Surg. 2017 Mar;9(1):1-9. doi: 10.4055/cios.2017.9.1.1. Epub 2017 Feb 13.
- 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 Spinal Cord 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 26 Apr 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 (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?
Rate of patients who decide to enroll in a spinal cord injury clinical study. (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 NCT05831163, 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 26 Apr 2023.