Traumatic Brain InjuryPhase 2NCT04291066
Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
A Phase 2 study testing N-Acetyl cysteine in people with Traumatic Brain Injury, run by HonorHealth Research Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- N-Acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2019to 1 Aug 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or older
- present to emergency department within 3 hours of documented TBI
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, 85020
HonorHealth Deer Valley Medical Center
Phoenix, Arizona, 85027
About this study
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.
Read the 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- N-Acetyl cysteine
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl cysteineDrug
Also called Multi-vitamins with minerals
Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | oral N-acetyl cysteine and oral multivitamin tablets Receives: Drug: N-Acetyl cysteine |
| Non-Treatment | No intervention | Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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.
Measured: 0 to 30 days post traumatic brain injury event
Secondary outcomes (1)
Glasgow Coma Scale (GCS) at Arrival and Discharge
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.
Measured: Day 0 Score on arrival through subject discharge post traumatic brain injury event at approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Sep 2019
- Primary completion30 Apr 2020
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryab mcPherson, DO, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291066
- Sponsor's protocol ID
- 1445221
- Status last verified
- Jan 2025
- First submitted
- 6 Dec 2019
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be published in peer-reviewed journal
Publications
Mcpherson RA, Mangram AJ, Barletta JF, Dzandu JK. N -acetylcysteine is associated with reduction of postconcussive symptoms in elderly patients: A pilot study. J Trauma Acute Care Surg. 2022 Nov 1;93(5):644-649. doi: 10.1097/TA.0000000000003639. Epub 2022 Apr 8.
PubMed 35393384
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Use of N-Acetylcysteine and Vitamins in the Treatment of TBI in Geriatric Patients
- ClinicalTrials.gov ID
- NCT04291066
- Acronym / sponsor ID
- 1445221
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: N-Acetyl cysteineoral N-acetyl cysteine and oral multivitamin tablets |
| Non-Treatment | No intervention | –Routine Care |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years or older
- present to emergency department within 3 hours of documented TBI
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl cysteineAlso: Multi-vitamins with mineralsCarbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI | Drug | Treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35393384Mcpherson RA, Mangram AJ, Barletta JF, Dzandu JK. N -acetylcysteine is associated with reduction of postconcussive symptoms in elderly patients: A pilot study. J Trauma Acute Care Surg. 2022 Nov 1;93(5):644-649. doi: 10.1097/TA.0000000000003639. Epub 2022 Apr 8.
- Individual participant dataSharing planned: No. Results will be published in peer-reviewed journal
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryab mcPherson, DO principal investigator
HonorHealth Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-Acetyl cysteine in people with Traumatic Brain Injury, run by HonorHealth Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.