An Interventional Trial for Persisting Post-Concussive Symptoms after Mild Traumatic Brain Injury

Not Applicable

• Conditions: Concussion; Mild traumatic brain injury; Persistent post-concussion symptoms; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12624000841572
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

i)Clinical diagnosis of concussion made by a medical practitioner
ii)Concussion experienced 6 months to 4 years ago
iii)Experiencing persistent post-concussion symptoms (PPCS)
iv)Aged 18 – 65 years
v)Willing and able to attend Sarich Neuroscience Research Institute – Curtin University precinct for the required time commitment (3x40 minute sessions per week for 6 weeks, baseline and follow up testing)
; i)Clinical diagnosis of concussion made by a medical practitioner
ii)Concussion experienced 6 months to 4 years ago
iii)Experiencing persistent post-concussion symptoms (PPCS)
iv)Aged 18 – 65 years
v)Willing and able to attend Sarich Neuroscience Research Institute – Curtin University precinct for the required time commitment (3x40 minute sessions per week for 6 weeks, baseline and follow up testing)

Exclusion Criteria

i)Significant history of pre-existing conditions that would interfere with assessment, intervention and follow-up (e.g. Substance abuse/alcohol abuse, homelessness, terminal illness)
ii)Significant debilitating pre-concussion diagnosed mental health disorder (e.g. schizophrenia, bipolar disorder)
iii)Significant pre-existing neurological condition which may interfere with ability to complete outcome measures, intervention or follow up (e.g. stroke, dementia)
iv)Pre-existing cognitive impairment (e.g. intellectual disability) which may interfere with ability to undertake assessment, intervention and follow up
v)Non-English speakers or poor English language skills which may interfere with ability to undertake assessment, intervention and follow up
vi)Pregnant women
vii)Prisoners in custody or people known to be involved in illegal activity
viii)Epilepsy or history of seizure
ix)Presence of surgical or other materials which may interfere with EEG signal e.g. aneurism clips, plates or screws, electronic inner ear implants, shrapnel or other foreign body.
x)Meets exclusion criteria to undertake MRI, which can be any of the following:
Has cardiac pacemaker or pacing wire in situ
Has metal surgical clips or staples of any kind (particularly aneurysm clips) in situ
Has had lap band surgery
Has electronic inner ear implants (bionic ears)
Has metal fragments in your eyes (past or present)
Has electronic stimulators
Has implanted pumps
Has metal pins or rods in bones
Has an IUCD (intrauterine contraceptive device) fitted
Has shrapnel, bullets or foreign bodies .
; i)Significant history of pre-existing conditions that would interfere with assessment, intervention and follow-up (e.g. Substance abuse/alcohol abuse, homelessness, terminal illness)
ii)Significant debilitating pre-concussion diagnosed mental health disorder (e.g. schizophrenia, bipolar disorder)
iii)Significant pre-existing neurological condition which may interfere with ability to complete outcome measures, intervention or follow up (e.g. stroke, dementia)
iv)Pre-existing cognitive impairment (e.g. intellectual disability) which may interfere with ability to undertake assessment, intervention and follow up
v)Non-English speakers or poor English language skills which may interfere with ability to undertake assessment, intervention and follow up
vi)Pregnant women
vii)Prisoners in custody or people known to be involved in illegal activity
viii)Epilepsy or history of seizure
ix)Presence of surgical or other materials which may interfere with EEG signal e.g. aneurism clips, plates or screws, electronic inner ear implants, shrapnel or other foreign body.
x)Meets exclusion criteria to undertake MRI, which can be any of the following:
Has cardiac pacemaker or pacing wire in situ
Has metal surgical clips or staples of any kind (particularly aneurysm clips) in situ
Has had lap band surgery
Has electronic inner ear implants (bionic ears)
Has metal fragments in your eyes (past or present)
Has electronic stimulators
Has implanted pumps
Has metal pins or rods in bones
Has an IUCD (intrauterine contraceptive device) fitted
Has shrapnel, bullets or foreign bodies .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Post-concussion symptom scale (PCSS)[Post-concussion symptom scale (PCSS) Baseline (pre-treatment), follow-up (week 7 post-treatment)];Change in Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Post-concussion symptom scale (PCSS)[Post-concussion symptom scale (PCSS) Baseline (pre-treatment), follow-up (week 7 post-treatment)]