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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291066
• Other study ID #: 1445221
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: HonorHealth Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 1, 2021
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Drug:
• N-Acetyl cysteine
Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI

Locations

Country	Name	City	State
United States	HonorHealth Deer Valley Medical Center	Phoenix	Arizona
United States	HonorHealth John C. Lincoln Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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