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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06264518
Other study ID # 56168915
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2025
Est. completion date March 2027

Study information

Verified date February 2024
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date March 2027
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Pregnant or nursing patients - Inability to perform regular electronic reporting - Patient does not understand, sign, and return consent form

Study Design


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who decide to enroll in a traumatic brain injury clinical trial 3 months
Primary Rate of patients who remain in traumatic brain injury clinical trial to trial completion 12 months
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