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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study aims to determine the effect of supplemental N-acetyl cysteine and additional multi-vitamin/mineral therapy on somatic, cognitive, and emotional post-concussion symptoms as determined by the Rivermeade Post-concussion Questionnaire (RPQ) within 24 hours of admission, post injury day 7, and post injury day 30. The RPQ questionnaires will be given to patients older than 60 years, who have been evaluated by the HonorHealth John C. Lincoln Medical Center or Deer Valley Medical Center trauma service within 3 hours of sustaining a traumatic brain injury (TBI).

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

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: N-Acetyl cysteine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>oral N-acetyl cysteine and oral multivitamin tablets | Drug: N-Acetyl cysteine<br>* Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI<br>* Other names: Multi-vitamins with minerals;|
| No Intervention: Non-Treatment<br>Routine Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Somatic, cognitive, and emotional post-concussion symptoms as measured by, RPQ scores within 24 hours of admission, post injury day 7, and post injury day 30. The scale goes based on a zero to 4 grading system. Zero equaling not experienced at all to 4 equaling a severe problem. | 1 to 30 days post traumatic brain injury event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of common post TBI symptoms | The severity of the five most common post TBI symptoms, including headache, nausea, sleep disturbance, poor concentration and forgetfulness/poor memory as measured by the scores of individual questions in the Rivermeade Post-concussion Questionnaire within 24 hours of admission, post injury day 7, and post injury day 30. Scale is 0 to 64 | 1 to 30 days post traumatic brain injury event |