Does n-acetyl cysteine hasten return to normal brain function in patients who have concussive head injury?

Phase 2

• Conditions: Mild traumatic brain injury; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12618001371280
• Lead Sponsor: MDHB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-15
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

>16 years old
head injury or significant deceleration injury t o torso with at least one of the following
Confusion or disorientation
Loss of consciousness Post trauma amnesia
other neurological abnormality - focal signs seizure intracranial lesion on CT

Exclusion Criteria

moderate or severe TBI (GCS <13 on ED arrival, Post traumatic amnesia >24h)
-need for hospital admission for any reason (due to the logistics of the study)
-Not living independantly
-Unable to take NAC for any reason
-Non resident in the area/ not able to follow up at 7 days
-Significant intoxication with alcohol or other drug (if patient is sober and able to provide informed consent at the time of discharge and otherwise meets study criteria, they are eligible for the study)
-Known cognitive impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who are symptom free at one week<br>Self reported <br>Do you feel as good as you did prior to injury with repsect to the following?<br>Headache Y/N<br>nausea Y/N<br>Balance Y/N<br>Difficulty with thinking or remebering Y/N<br>Emotional symptoms (irritability, lethargy, mood) Y/N<br><br>[One week post injury]

Secondary Outcome Measures

Name	Time	Method
Objective tool- Tablet based Braincheck neurocognitive 'game' [One week];Proportion of patients symptom free at one month<br>Self reported<br>Do you feel as good as you did prior to injury with repsect to the following?<br>Headache Y/N<br>nausea Y/N<br>Balance Y/N<br>Difficulty with thinking or remembering Y/N<br>Emotional symptoms (irritability, lethargy, mood) Y/N<br><br><br>[One month]