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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04291066
Other study ID # 1445221
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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