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

Phase 2

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Drug: N-Acetyl cysteine

• Registration Number: NCT04291066
• Lead Sponsor: HonorHealth Research Institute

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Primary Completion: 2020-04-30
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	N-Acetyl cysteine	oral N-acetyl cysteine and oral multivitamin tablets

Primary Outcome Measures

Name	Time	Method
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.	1 to 30 days post traumatic brain injury event	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".

Secondary Outcome Measures

Name	Time	Method
Severity of common post TBI symptoms	1 to 30 days post traumatic brain injury event	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

Trial Locations

Locations (2)

HonorHealth Deer Valley Medical Center; 🇺🇸 Phoenix, Arizona, United States

HonorHealth John C. Lincoln Medical Center; 🇺🇸 Phoenix, Arizona, United States