Analyzing Clinical Research Participation of Patients With Spinal Cord Injury

NCT05831163 | Not Yet Recruiting

• 1 other identifier: 83050803
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; spinal cord injury

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a spinal cord injury clinical study.

  3 months

• Number of spinal cord injury study participants who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are actively considering involvement in an observational spinal cord injury clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• Aged ≥ 18 years old
• Ability to understand and the willingness to sign a written informed consent document.
• Diagnosis of spinal cord injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 33620185 BACKGROUND

• 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.

  PMID: 32498423 BACKGROUND

• 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.

  PMID: 28261421 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04