Traumatic Brain Injury
Conditions
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).
Interventions
DRUGN-Acetyl cysteine
Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
Sponsors
HonorHealth Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Coma Scale (GCS) at Arrival and Discharge | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRyab mcPherson, DO
HonorHealth Research Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 46 | 7 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 2 / 46 | 7 / 46 |
Outcome results
None listed