Brain Injuries Clinical Trial
Official title:
A Study Analyzing Brain Injury Patients Experience Patterns in Medical Trials
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | February 2026 |
| Est. primary completion date | February 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Patient does not understand, sign, and return consent form - Patient is pregnant - Inability to perform regular electronic reporting |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to enroll in a brain injury clinical trial. | 3 months | ||
| Primary | Rate of patients who remain in brain injury clinical trial to trial completion. | 12 months |
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