Skip to content

Modification of Brain Rhythms on Intensity of Chronic Eye Pain

Efficacy of electroencephalography neurofeedback for neuropathic eye pain using a single case experimental design study with multiple baselines on four participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000173695
Enrollment
4
Registered
2023-02-21
Start date
2023-09-12
Completion date
2023-10-19
Last updated
2025-09-22

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

Conditions

None listed

Brief summary

Neuropathic eye pain (NEP) is a debilitating pain condition that is difficult to treat. NEP remains minimally responsive to existing pharmacological and non-pharmacological treatments. Although further studies are required to more definitively evaluate its efficacy as a treatment for alleviating NEP, there is growing evidence to suggest that electroencephalography (EEG) neurofeedback has the potential to reduce neuropathic eye pain. We have developed a novel EEG neurofeedback system to reduce NEP using openBCI technology, which incorporates the capturing and recording of EEG, and the delivery of neurofeedback via an interactive gaming interface. To achieve a reduction in NEP, we will use a neuromodulation protocol that targets and suppresses theta (4-8 Hz) and high beta frequency (20-30 Hz) power bands and enhances alpha (9-12 Hz) frequency power bands. A single-case experimental design (SCED) with multiple baselines will be used to examine the efficacy of our self-developed EEG neurofeedback treatment for the alleviation of NEP. Four participants with NEP will be recruited. Each participant will be randomly assigned to a different baseline phase (i.e., 7, 10, 13 or 16 days), which will then be followed by twenty 30-minute EEG neurofeedback sessions over a 4-week period. The Numerical Rating Scale will be used to assess average pain intensity, which will serve as the primary outcome measure. Pain interference will serve as the secondary outcome measure and will be measured using 6 items from the Brief Pain Inventory. Generalisation measures will be used to measure efficacy of the intervention beyond the primary and secondary outcomes and will assess quality of life, sleep quality, symptoms of anxiety and depression, mood and well-being. Satisfaction and feasibility of the intervention will be measured using self-reporting questionnaires and an unstructured interview. SCED trials are considered a viable alternative approach to randomised control trials when identifying evidence-based practices in the field of technology-based health interventions, when recruitment of large samples is not feasible.

Interventions

This study will be conducted using a single-case experimental design (SCED) with multiple baselines across participants. The SCED method involves repeatedly assessing the dependent variables (i.e., pain intensity, pain interference) for each of the participants for the duration of the trial, across all phases. This study will use a design of AB + follow-ups, where 'A' refers to the baseline phase, 'B' is the intervention phase, and there will be two follow-up phases that follow. Four participant

This study will be conducted using a single-case experimental design (SCED) with multiple baselines across participants. The SCED method involves repeatedly assessing the dependent variables (i.e., pain intensity, pain interference) for each of the participants for the duration of the trial, across all phases. This study will use a design of AB + follow-ups, where 'A' refers to the baseline phase, 'B' is the intervention phase, and there will be two follow-up phases that follow. Four participants will be randomly assigned to different baseline durations of the SCED. In this study, one week (i.e., 7 days of observation) will be considered as a stable baseline. Each baseline phase will be followed by the intervention phase, where participants will complete twenty days of 30-minute EEG neurofeedback sessions over a 4-week period. There will be a 1-week follow-up for each participant immediately after completion of the intervention. Staggered baseline phases will be used under the SCED to ensure that stability is achieved. This will mean that all participants will start their baseline phase on the same day, but the baseline for the first participant will be 7 days, the second participant will have a baseline of 10 days, the third participant will have a baseline of 13 days and the fourth participant will have a baseline of 16 days. Each baseline phase will be followed by the intervention phase, where participants will each complete twenty days of 30-minute EEG neurofeedback sessions over a 4-week period. Following the intervention phase, there will be a 1-week follow up for each participant immediately after completion of the intervention. In addition, a further 1-week follow-up will take place five weeks after completion of the intervention. At the beginning of the baseline phase, each participant will complete self-report questionnaires for the primary and secondary outcomes in the form of a pain journal. Participants will continue to complete this pain journal during the intervention and follow-up phases, in order to monitor for changes in pain intensity and pain interference. Participants will be contacted every day to ensure that they're completing their pain journals at the appropriate times. Each EEG neurofeedback session will be self-administered by participants in their homes. Each participant will complete twenty days of 30-minute EEG neurofeedback sessions over a 4-week period. Each session is comprised of three 5-minute intervals of EEG neurofeedback, with 3-minute breaks in between. Before starting each EEG neurofeedback session, participants will run an impedance check, to ensure the EEG device is positioned correctly and is accurately recording brain activity. The EEG neurofeedback treatment incorporates an EEG headset used to record and capture brain activity to be developed in-house and the interactive gaming interface that has been developed using the Unity3D game engine (Unity Technologies, USA). The neuromodulation treatment protocol targets and suppresses theta and low alpha (4-8 Hz) and high beta (20-30 Hz) frequency band powers and enhances high alpha (9-12 Hz) frequency band powers, which teaches participants to enter a mindful state, dampening pain signalling. During each EEG neurofeedback session, neurofeedback will be performed by recording and capturing the frequency bands of interest (i.e., 4-8 Hz, 9-12 Hz and 20-30 Hz) and relaying the information to the interactive gaming interface, which then provides visual feedback based on the activity recorded: when only one EEG frequency band power is suppressed or reinforced as desired, the game avatar will change colour; when two frequency band powers are activated correctly, the game avatar starts to move forward; and when all three frequency band powers are activated, the gaming background changes colour which indicates that participants have entered a mindful state. Participants will accumulate points for the amount of time they spend in this mindful state (i.e., number of seconds that a participant keeps all three frequency power bands activated). Hence, the aim of the game is to accumulate as many points as possible.

Sponsors

University of New South Wales Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

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

Inclusion criteria

Four individuals with neuropathic eye pain will be recruited for this study. Participants need to meet the following inclusion criteria: (1) a diagnosis of neuropathic eye pain based on clinical history, ocular and non-ocular pain symptoms, and structure and function of the corneal nerves, (2) neuropathic eye pain persisting for longer than 6 months, (3) average pain rating = or more than 3 over the last seven days (out of 10) on the Numerical Rating Scale (0 reflecting no pain and 10 reflecting maximum pain), (4) fluent in speaking and reading English, (5) not currently undergoing any changes to current eye pain treatment or eye procedures and (6) able to fully participate in the EEG neurofeedback intervention and is willing to complete all 20 sessions over the four-week intervention period.

Exclusion criteria

The key exclusion criteria are as follows: (1) diagnosis of a severe neurodegenerative and/or psychiatric disorder, (2) average pain rating < 3 over the last seven days (out of 10) on the Numerical Rating Scale (0 reflecting no pain and 10 reflecting maximum pain), (3) eye pain limiting prolonged exposure to digital screens for 20 minutes (comprises approximately one session of EEG neurofeedback), (4) individuals unable to complete twenty consecutive days of EEG neurofeedback treatment and (5) individuals located outside of Australia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026