An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury

NCT06264518 | Not Yet Recruiting

• 1 other identifier: 56168915
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical study participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

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

  3 months

• Rate of patients who remain in traumatic 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

Quantity of participants in traumatic brain injury study who sustain participation until study completion

You may qualify if:

• Patient has been diagnosed with traumatic brain injury
• Patient has self-identified as planning to enroll in an observational clinical trial
• Patient is a minimum of 18 years or older

You may not qualify if:

• Pregnant or nursing patients
• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Giner J, Mesa Galan L, Yus Teruel S, Guallar Espallargas MC, Perez Lopez C, Isla Guerrero A, Roda Frade J. Traumatic brain injury in the new millennium: new population and new management. Neurologia (Engl Ed). 2022 Jun;37(5):383-389. doi: 10.1016/j.nrleng.2019.03.024. Epub 2021 Apr 29.

  PMID: 35672125 BACKGROUND

• Hagos A, Tedla F, Tadele A, Zewdie A. Pattern and Outcome of Traumatic Brain Injury, Addis Ababa, Ethiopia: A Cross-sectional Hospital-based Study. Ethiop J Health Sci. 2022 Mar;32(2):343-350. doi: 10.4314/ejhs.v32i2.15.

  PMID: 35693562 BACKGROUND

• Shrestha A, Paudel N, Adhikari G, Shrestha S, Lamichhane S, Subedi S, Jaishwal N. Traumatic Brain Injury among Patients Admitted in Neurosurgical Unit in a Tertiary Care Centre: A Descriptive Cross-sectional Study. JNMA J Nepal Med Assoc. 2023 Jun 1;61(262):514-518. doi: 10.31729/jnma.8197.

  PMID: 37464844 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; 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: February 9, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)