CompletedPhase 2

Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients

United States92 participantsStarted 2019-09-01

Plain-language summary

This study will evaluate the administration of N-Acetyl-cysteine in combination with multi-vitamins/minerals in geriatric population (\>60 years of age) who have experienced a traumatic brain injury.

Who can participate

Age range

60 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 60 years or older * present to emergency department within 3 hours of documented TBI Exclusion Criteria: * patients without TBI * patients with a history of TBI greater than 3 hours prior to presentation * patients under the age of 60 * currently enrolled in an ongoing research study * patients who at baseline prior to the TBI, cannot participate in cognitive function testing (aphasia, severe dementia, non verbal; prior to TBI) * Patients who are unable to tolerate PO medications within 3 hours of sustaining TBI.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine Improvement in Somatic, Cognitive, and Emotional Post-concussion Symptoms as Measured by the Rivermeade Post-concussion Questionnaire (RPQ) in Treatment Group vs Non-treatment Group.

Timeframe: 0 to 30 days post traumatic brain injury event

Trial details

NCT IDNCT04291066

SponsorHonorHealth Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-30

Results submitted2024-06-27

View on ClinicalTrials.gov More Traumatic Brain Injury trials

Who can participate

Age range

60 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.