None listed
Conditions
Brief summary
Chronic pain is a significant healthcare problem and with a global prevalence of 20-30%, this is a major cause of suffering. Of particular interest, fibromyalgia is a neuropathic pain condition that causes widespread musculoskeletal pain, accompanied by secondary symptoms involving fatigue, memory, sleep and mood disturbances. Current treatments (e.g. pharmacotherapy) has only moderate effect and is associated with many adverse effects. Development of new treatments is therefore warranted. The cortical areas involved in chronic pain include the somatosensory cortex (S1) as well as the pregenual anterior cingulate cortex (pgACC). Recent studies have shown that the effective connectivity from pgACC to S1 is dysfunctional in pain, suggesting that pain cannot be inhibited anymore, disrupting the physiological balance. Treatment techniques that can strengthen the effective connectivity from the pgACC to the SSC may result in pain suppression. Electroencephalography based Neurofeedback (EEG NF), is a brain-computer interface technique that facilitates an individual’s ability to self-control their brain activity. EEG NF can be used to influence the electrical activity and functional connectivity between the targeted brain regions (pgACC, S1); thereby could improve pain modulation. This study will explore a novel EEG-based NF technique, targeting directional functional connectivity in the alpha-band from pgACC to S1 region.
Interventions
Electroencephalogram based Neurofeedback (EEG NF) will be administered three times a week (30 min/session) for a total of four weeks (i.e., 12 sessions) by the researcher experienced in delivering neuromodulation techniques, using a 21 channel DC coupled amplifier produced by Brainmaster Inc. During each session, participants will be asked to sit on a chair with back supported and relaxed for 10 minutes, which allows the trainer to prepare the participant for NF training. The Comby EEG lead cap
Electroencephalogram based Neurofeedback (EEG NF) will be administered three times a week (30 min/session) for a total of four weeks (i.e., 12 sessions) by the researcher experienced in delivering neuromodulation techniques, using a 21 channel DC coupled amplifier produced by Brainmaster Inc. During each session, participants will be asked to sit on a chair with back supported and relaxed for 10 minutes, which allows the trainer to prepare the participant for NF training. 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 EEG. Active-NF treatment group: Participants will be instructed to close their eyes, relax, and listen to the sound being played. The system delivers sound feedback (reward) each time the participant's brain activity meets the desired threshold at the targeted brain regions: pregenual anterior cingulate cortex (pgACC) and the primary somatosensory cortex (S1). For the current study, we have developed NF program to reinforce and train the real-time EEG functional connectivity from pgACC to the S1 in the alpha band. For all the active-NF treatment groups, the reward threshold will be adjusted in real-time between 60-80%, i.e., for 60-80% of the time, sound feedback (reward) will be delivered by the system when the participant's functional connectivity at the targeted regions meets the desired alpha magnitude (threshold). The intervention will be delivered individually to participants by a researcher trained in delivery of EEG NF. This will be delivered face-to-face in a hospital-based setting. The researcher will monitor adherence to the intervention by recording sessions attended with a checklist.
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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants with a diagnosis of fibromyalgia will be eligible to participate. To be included in the study, participants must meet all of the following inclusion criteria: • Capable of understanding and signing an informed consent form • Age between 18 to 75 years on the day of the consent • Satisfy the Modified American Collage of Rheumatology (ACR) 2011 Fibromyalgia Diagnostic Criteria • A score greater than or equal to 4 on the 11-point numeric pain rating scale (NPRS, 0=No pain to 10=Worst pain) in the past 7 days • A disability score of greater than or equal to 50 on Fibromyalgia Impact Questionnaire
Exclusion criteria
Participants who meet any of the following conditions will be excluded: • Neurological conditions • Cognitive and psychiatric disorders • Epilepsy • Seizures • Substance abuse • Pregnant or six-months post-partum
Outcome results
None listed