Examining the Experiences of Brain Injury Patients in Medical Trials

NCT ID: NCT05690919

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injuries

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

4159004227

References

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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.

Reference Type BACKGROUND
PMID: 20129503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30465951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33161752 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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84028751

Identifier Type: -

Identifier Source: org_study_id

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