Examining the Experiences of Brain Injury Patients in Medical Trials

NCT05690919 | Not Yet Recruiting

• 1 other identifier: 84028751
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in a brain injury clinical trial.

  3 months

• Rate of patients who remain in brain injury clinical trial to trial 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

Brain injury patients who are actively considering enrolling in an intensive clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

• Patient does not understand, sign, and return consent form
• Patient is pregnant
• Inability to perform regular electronic reporting

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 20129503 BACKGROUND

• Wat 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.

  PMID: 30465951 BACKGROUND

• Kjeldsen 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.

  PMID: 33161752 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; 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: January 10, 2023
• First Posted: January 19, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-06