Analyzing Clinical Research Participation of Patients With Spinal Cord Injury

• Sponsor: Power Life Sciences Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05831163
• Collaborator: (none)
• Enrollment: 500
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: A Review of Clinical Trial Experiences and Trends From Spinal Cord Injury Patients
• Anticipated Study Start Date: May 1, 2024
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: May 1, 2026

Outcome Measures

Primary Outcome Measures

1. Rate of patients who decide to enroll in a spinal cord injury clinical study. [3 months]

2. Number of spinal cord injury study participants who remain in clinical trial until completion. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged ≥ 18 years old

• Ability to understand and the willingness to sign a written informed consent document.

• Diagnosis of spinal cord injury

Exclusion Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Power Life Sciences Inc.

Investigators

• Study Director: Michael B Gill, Power Life Sciences Inc.

Study Documents (Full-Text)

• Informed Consent Form - Apr 13, 2023

More Information

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.
• Kim 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.
• Yamazaki 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.

• Responsible Party: Power Life Sciences Inc.
• ClinicalTrials.gov Identifier: NCT05831163
• Other Study ID Numbers: 83050803
• First Posted: Apr 26, 2023
• Last Update Posted: Apr 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Power Life Sciences Inc.: Spinal Cord Injuries; spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Apr 26, 2023