Modification of Brain Rhythms on Intensity of Chronic Eye Pai

Not Applicable

Completed

• Conditions: europathic Eye Pain; Neuropathic Eye Pain; Eye - Diseases / disorders of the eye; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000173695
• Lead Sponsor: niversity of New South Wales Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-21
• Study Completion: 2024-01-25
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Numerical Rating Scale (NRS) will serve as the primary outcome measure of neuropathic eye pain. The NRS assesses pain intensity on a 0-10 scale (0 = no pain and 10 = maximum pain imaginable).[ Participants in this study will be asked to rate the average intensity of their pain at the same time on one occasion each and every day, for the duration of the trial. If by the end of the trial any ratings are missing, the score will be averaged using the ratings obtained. Pain intensity will be recorded by participants in their pain journals, using paper-and-pencil. They will record pain intensity every day during all phases: baseline (7, 10, 13 or 16 days), intervention (28 days), and two follow-up (7 days) phases. ]

Secondary Outcome Measures

Name	Time	Method
The degree of pain interference experienced by each participant will be assessed using 6 items from the Brief Pain Inventory. These items assess how each participant's eye pain interferes with aspects of daily life: general activity, normal work, relations with other people, enjoyment of life, mood and sleep. For each of these six aspects, pain interference will be graded on a 0-10 scale (0 = does not interfere and 10 = completely interferes).[ Like pain intensity, degree of pain interference will be measured on one occasion, every day during all phases of the trial: baseline, intervention and both follow-up phases.]