Feasibility and Safety of a Home-based Electroencephalogram Neurofeedback Intervention to Reduce Chronic Neuropathic Pain: A Cohort Clinical Trial

• Published in: Archives of rehabilitation research and clinical translation Vol. 6; no. 3; p. 100361
• Main Authors: Sakel, Mohamed, Saunders, Karen, Ozolins, Christine, Biswas, Riya
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2024; Elsevier
• Subjects: Brain computer interface; Chronic neuropathic pain; Feasibility; Home-based neurofeedback; Original Research; Rehabilitation; Safety; PCS; NP; CNP; Brain computer interface; EuroQOL-5D-5L; NFB; FU; VAS (Pain); P; SE; CSI; DASS21; Chronic neuropathic pain; Safety; AE; EEG; IT; CP; Home-based neurofeedback; PIP; PI; IRAS; Feasibility; BPI; Rehabilitation; CoI; TP; PSQI
• ISSN: 2590-1095; 2590-1095
• DOI: 10.1016/j.arrct.2024.100361

•Home-based neurofeedback is feasible for people with chronic neuropathic pain.•Accessibility was 48% (11/23) with a 2:1 ratio of participant screening to enrollment.•Overall safety was good with no serious adverse events recorded.•Tolerability and acceptability were measured as 26% (6/23).•Improvements were detected in pain levels, mood, and central sensitization scores. To evaluate the feasibility, safety, and potential health benefits of an 8-week home-based neurofeedback intervention. Single-group preliminary study. Community-based. Nine community dwelling adults with chronic neuropathic pain, 6 women and 3 men, with an average age of 51.9 years (range, 19-78 years) and with a 7-day average minimum pain score of 4 of 10 on the visual analog pain scale. A minimum of 5 neurofeedback sessions per week (40min/session) for 8 consecutive weeks was undertaken with a 12-week follow-up baseline electroencephalography recording period. Primary feasibility outcomes: accessibility, tolerability, safety (adverse events and resolution), and human and information technology (IT) resources required. Secondary outcomes: pain, sensitization, catastrophization, anxiety, depression, sleep, health-related quality of life, electroencephalographic activity, and simple participant feedback. Of the 23 people screened, 11 were eligible for recruitment. One withdrew and another completed insufficient sessions for analysis, which resulted in 9 datasets analyzed. Three participants withdrew from the follow-up baselines, leaving 6 who completed the entire trial protocol. Thirteen adverse events were recorded and resolved: 1 was treatment-related, 4 were equipment-related, and 8 were administrative-related (eg, courier communication issues). The human and IT resources necessary for trial implementation were identified. There were also significant improvements in pain levels, depression, and anxiety. Six of 9 participants perceived minimal improvement or no change in symptoms after the trial, and 5 of 9 participants were satisfied with the treatment received. It is feasible and safe to conduct a home-based trial of a neurofeedback intervention for people with chronic neuropathic pain, when the human and IT resources are provided and relevant governance processes are followed. Improvements in secondary outcomes merit investigation with a randomized controlled trial.