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

Intervention for Persisting Post-Concussive Symptoms after Mild Traumatic Brain Injury in adults aged 18 - 65 years

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000841572
Acronym
PPCS
Enrollment
84
Registered
2024-07-08
Start date
2024-07-22
Completion date
2025-07-21
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This purpose of this study is to examine whether new brain training regimes (active interventions) can influence brain function and reduce persistent post-concussion symptoms. This study will compare two different types of brain training to the “standard treatment”, which for mTBI is no treatment other than symptom management (control with no intervention). This will aid in determining whether people in the brain training groups have less symptoms because of brain training, or whether they would have had a reduction in symptoms anyway during that time.

Interventions

Group 1: Neurofeedback Neurofeedback sessions will train brain specific brain regions using real-time feedback of the individual’s electrophysiological brain activity. Participants allocated to the neurofeedback group will attend the Sarich Neuroscience Research Institute – Curtin University laboratory for 18 neurofeedback sessions (3 sessions/week for 6 weeks). Each neurofeedback session is expected to take approximately 40 minutes, including time to fit the Electro-Cap, fill the electrodes and

Group 1: Neurofeedback Neurofeedback sessions will train brain specific brain regions using real-time feedback of the individual’s electrophysiological brain activity. Participants allocated to the neurofeedback group will attend the Sarich Neuroscience Research Institute – Curtin University laboratory for 18 neurofeedback sessions (3 sessions/week for 6 weeks). Each neurofeedback session is expected to take approximately 40 minutes, including time to fit the Electro-Cap, fill the electrodes and achieve good impedance, and perform rounds of neurofeedback. Neurofeedback will be conducted in 7 rounds, with 3 minutes of training and 30-second breaks in between, for a total neurofeedback time of 24.5 minutes. Participants will sit facing a computer monitor and see an electroencephalography (EEG) map on the screen. A research team member will remain with the participant, directly observing the participant as the complete the intervention. They will be given instruction on what the training will involve (i.e. meeting a target), but as an operant conditioning method will not receive specific instruction on how that is to be achieved. Instead, when the target brain behaviour is achieved, the participant is rewarded with a sound and appearance of a circle on the screen. The participant receives a score for each round which indicates their performance in achieving that target. Over time, the participant learns to regulate their own brain activity, though often they are not consciously aware of the learning mechanism. Target Z scores will be gradually reduced over each session based on improvement in performance. For example, a participant with a Z score of +3 (over-activation) will train to reduce brain activation in that area with a target Z score of 2.5. When this is achieved and maintained, the Z score will be reduced to 2, then 1.5, and so on, until the Z score is returned to a ‘normal’ score of 0. Group 2: Concentration This group will be recruited as a comparator to neurofeedback, to allow delineation of neurofeedback effects from effects of repeated focused concentration on a screen, participant-therapist interaction, environment, or other factors which may be associated with neurofeedback (but are not, in themselves, neurofeedback). This group will be informed that they are participating in a trial of concentration as a therapy for persistent post-concussive symptoms (PPCS). Participants allocated to the concentration group will attend the Sarich Neuroscience Research Institute – Curtin University laboratory for 18 concentration sessions (3 sessions/week for 6 weeks). To match the neurofeedback experience, each session is expected to take approximately 40 minutes (including fitting and filling of the Electro-Cap, etc.), with 7 rounds of 3 minute concentration and 30-second breaks in between, for a total time of 24.5 minutes. Participants will sit facing a computer monitor and see an EEG map on the screen. They will be given instruction to look at the screen and pay particular attention when a sound plays and circle appears on the screen. A research team member will remain with the participant, directly observing the participant as the complete the intervention. For this group, the sound and circle will appear at random.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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)

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 .

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026