None listed
Conditions
Brief summary
This is a pilot RCT involving randomization, double-blinding (participant and assessor), two-arm, parallel, sham-controlled trial. The participant will be randomized to receive either ISF-NF or sham ISF-NF. All the participants are expected to undergo 9 treatment sessions and two assessment sessions during the entire course of the study. The primary outcomes of the study is intended to look at the feasibility, safety and adverse effect measures for tailoring a future fully powered RCT.
Interventions
Participants allocated to the intervention group will required to attend nine sessions (30 minutes; three sessions/week) of Infraslow Fluctuation-Neurofeedback (ISF-NF) treatment at the school of physiotherapy and two 90-minute sessions for undergoing baseline (S1) and post-intervention assessments (S11).
During each session, participants will be asked to sit on a chair with back supported, and relaxed for 10 minutes, that allows the trainer (University research student) to prepare the particip
Participants allocated to the intervention group will required to attend nine sessions (30 minutes; three sessions/week) of Infraslow Fluctuation-Neurofeedback (ISF-NF) treatment at the school of physiotherapy and two 90-minute sessions for undergoing baseline (S1) and post-intervention assessments (S11). During each session, participants will be asked to sit on a chair with back supported, and relaxed for 10 minutes, that allows the trainer (University research student) to prepare the participant for NF training. Both ISF-NF and sham ISF-NF will be administered using a 21 channel DC coupled amplifier produced by Brainmaster Inc. The Comby EEG lead cap with sensors (Ag/AgCl) will be fixed to the individual’s scalp, with reference electrodes placed at the mastoids. The impedance of the active electrodes will be monitored through the Mitsar amplifier and will be kept below 5 kilo-ohms. The participants will also be emphasized to minimize the eyeball movement, head and neck movements, swallowing, and clenching of teeth to minimize motion artifact in electroencephalogram (EEG). Participants will be instructed to close their eyes, relax and listen to the sound being played. A distinct tone will be played when the participant’s brain activity meets ISF (0.0 to 0.1 Hz) magnitude (threshold) at the following cortical areas of the brain: somatosensory cortex (SSC), dorsal anterior cingulate cortex (dACC) and pregenual anterior cingulate cortex (pgACC). The brain regions are chosen based on brain imaging studies on KOA and previous NF studies. Training will be intended to down-train SSC and dACC activity, simultaneously with up-training of pgACC. Efforts will be made to keep the reward threshold in real-time between 60-80%. In other words, for 60-80% of the time, a sound will be played (reward) when the participant's brain activity meets the infraslow magnitude (threshold).
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
44 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 44-75 years, with a clinical diagnosis of knee OA; with pain (at least = four on an 11-point numerical rating scale) for a minimum duration of three months will be eligible to participate in the study.
Exclusion criteria
• Underwent surgery or other invasive procedures in the last six months and any surgical procedures scheduled within 8 weeks after screening. • Undertaken any steroid injections to the knee joint in the past three months or on oral steroids in the previous month. • Current intake of centrally acting medications (e.g. antidepressants, anticonvulsants, neuropathic pain drugs) or intention of taking new medications in the next 8 weeks. • Neurological conditions/diseases (brain, spinal cord or peripheral nerve injuries, radiculopathy and neuropathies). • Soft tissue injuries of the knee (e.g. meniscus/muscle/tendon/ligament injury) in the last 3 months. • Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease). • Difficulty or inability to read or understand English. • Hearing problems (hearing loss, tinnitus) and ear infections. • Pregnancy or six months post-labour.
Outcome results
None listed