NCT06288698

Brief Summary

Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation. The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

February 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 23, 2024

Last Update Submit

February 23, 2024

Conditions

Keywords

TBI

Outcome Measures

Primary Outcomes (2)

  • Number of TBI patients who decide to enroll in a clinical research

    3 months

  • Rate of TBI patients who remain in clinical trial to trial completion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with TBI who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document
  • Participant must be 18 years of age or older
  • Confirmed diagnosis of TBI

You may not qualify if:

  • Enrolled in another research study
  • Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
  • Inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • Perry DC, Sturm VE, Peterson MJ, Pieper CF, Bullock T, Boeve BF, Miller BL, Guskiewicz KM, Berger MS, Kramer JH, Welsh-Bohmer KA. Association of traumatic brain injury with subsequent neurological and psychiatric disease: a meta-analysis. J Neurosurg. 2016 Feb;124(2):511-26. doi: 10.3171/2015.2.JNS14503. Epub 2015 Aug 28.

    PMID: 26315003BACKGROUND
  • Kaur P, Sharma S. Recent Advances in Pathophysiology of Traumatic Brain Injury. Curr Neuropharmacol. 2018;16(8):1224-1238. doi: 10.2174/1570159X15666170613083606.

    PMID: 28606040BACKGROUND
  • VanderVeen JD. TBI as a Risk Factor for Substance Use Behaviors: A Meta-analysis. Arch Phys Med Rehabil. 2021 Jun;102(6):1198-1209. doi: 10.1016/j.apmr.2020.10.112. Epub 2020 Nov 2.

    PMID: 33152264BACKGROUND

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 1, 2024

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations