TBI Clinical Trial
Official title:
Analyzing Enrolment and Engagement Trends in Individuals Confronting TBI: Insights From TBI Clinical Trials
| NCT number | NCT06288698 |
| Other study ID # | 53955721 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2025 |
| Est. completion date | March 2027 |
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.
| 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: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Kaur P, Sharma S. Recent Advances in Pathophysiology of Traumatic Brain Injury. Curr Neuropharmacol. 2018;16(8):1224-1238. doi: 10.2174/1570159X15666170613083606. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of TBI patients who decide to enroll in a clinical research | 3 months | ||
| Primary | Rate of TBI patients who remain in clinical trial to trial completion | 12 months |
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|---|---|---|---|
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