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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HonorHealth Deer Valley Medical Center, Phoenix, Arizona, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl cysteine

Drug

Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI

Other names: Multi-vitamins with minerals

Primary outcomes

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.

Time frame: 0 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 (Day 0), post injury (Day 7), and post injury (Day 30). The scale goes based on a 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, 4 = a severe problem. The RPQ scores can range between 0 and 64 where higher scores indicate more severe symptoms.

Secondary outcomes

Glasgow Coma Scale (GCS) at Arrival and Discharge

Time frame: Day 0 Score on arrival through subject discharge post traumatic brain injury event at approximately 30 days

The Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness after a brain injury. The scale covers three primary domains with associated sub scores to generate a total GCS score ranging from 3 - 15. A total score of 3 -8 notes severe dysfunction, 9 - 12 moderate dysfunction, and 13 - 15 mild dysfunction. Sub scores are evaluated as follows:

Eye Opening (Score range 1 -4): 1 - None, 2 - To pressure, 3 - To sound, 4 - Spontaneous.

Verbal Response (Score range 1-5): 1 - None, 2 - Sounds, 3 - Words, 4 - Confused, 5 - Orientated.

Motor Response (Score range 1-6): 1 - None, 2 - Extension, 3 - Abnormal flexion, 4 - Normal flexion, 5 - Localizing, 6 - Obey commands.

Sponsors and collaborators

Lead sponsor

HonorHealth Research Institute

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Mar 2, 2020
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed