None listed
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility and safety of the targeted EEG based infraslow frequency neurofeedback (ISF-NF) technique in individuals with chronic low back pain (CLBP), and to explore its effects on pain, function and psychological measures in individuals with CLBP. Neurofeedback is a non-invasive technique for augmenting or inhibiting brain activity patterns associated with pain by modifying one’s brain signal through feedback induced learning. The activity in the brain regions [pregenual anterior cingulate cortex (pgACC), dorsal anterior cingulate cortex (dACC) and primary somatosensory cortex (SSC)] targeted in the current study have been demonstrated to be altered in individuals with CLBP. We propose to explore a novel EEG based infraslow frequency neurofeedback (ISF-NF)technique targeting the pgACC, dACC, and SSC individually as well as simultaneously. The ISF-NF technique has been specifically developed to modulate the infraslow electrical activity (0-0.1 Hz) in the brain. The infraslow electrical activity, a fundamental frequency range of the brain, re-organises neurons, regulate oscillatory patterns in the brain during awake and sleep cycles, and improves the electrical connectivity of the brainwide functional networks; thereby improve clinical outcomes. The evidence obtained from this study will thus help us to develop novel interventions to improve the health outcomes (pain and function) in individuals with CLBP.
Interventions
Electroencephalography based infraslow frequency (o.o1-0.1 Hz) neurofeedback (ISF-NF) will be administered three times a week (30 minutes/ session) for a total of 4 weeks, by an experienced researcher. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back supported. No form of stimulus will be given. The Comby EEG lead cap with sensors will be placed on the individual’s scalp. The targeted brain regions will include the pregenual anterior cingul
Electroencephalography based infraslow frequency (o.o1-0.1 Hz) neurofeedback (ISF-NF) will be administered three times a week (30 minutes/ session) for a total of 4 weeks, by an experienced researcher. During each session, participants will be asked to close their eyes and sit relaxed on a chair with back supported. No form of stimulus will be given. The Comby EEG lead cap with sensors will be placed on the individual’s scalp. The targeted brain regions will include the pregenual anterior cingulate cortex (pgACC), dorsal anterior cingulate cortex (dACC), and primary somatosensory cortex (SSC). For the active ISF-NF treatment groups, the Brainmaster Inc. system delivers a sound feedback (reward) each time the participant’s real-time brain activity at the targeted regions meets the desired infraslow threshold (0.0–0.1 Hz). The infraslow activity will be up-trained at the pgACC (Group 1), down-trained at the dACC+SSC (Group 2), and simultaneously up-trained at pgACC and down-trained at dACC+SSC (i.e., training ratio) (Group 3). For all the active ISF-NF treatment groups, the reward threshold will be adjusted in real-time between 60-80%, i.e., for 60-80% of the time, a sound feedback (reward) will be delivered by the system when the participant's real-time brain activity at the targeted regions meets the desired infraslow magnitude (threshold). For placebo ISF-NF treatment group, a pre-recorded sound feedback will be played to create an identical auditory feedback to the active treatment groups.
Sponsors
Dr Divya Adhia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants with a diagnosis of CLBP 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 • Pain in the lower back area (region between the 12th rib and the gluteal fold) that occurs every day for more than or equal to 3 months • A score of more than or equal to 4 on the 11-point numeric pain rating scale (NPRS, 0 is No pain to 10 is Worst pain) in the past 4 weeks • A disability score of more than or equal to 5 on Roland–Morris Disability Questionnaire
Exclusion criteria
• Inflammatory arthritis • Undergoing any therapy from a health professional (e.g. physiotherapists or chiropractor) • Recent soft tissue injuries of the back in the last 3 months • History of surgery to the back region • Radicular pain and radiculopathy • History of neurological diseases • Unstable medical or psychiatric conditions • History of epilepsy or seizures • Presence of any peripheral neuropathy or vascular pathology • Sleep Apnoe • Hearing problems (hearing loss or tinnitus) • Alcohol or substance abuse • Dyslipidaemia • Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease): A total score of 24 or below on Mini-Mental State Examination • History of uncontrolled/untreated hypertension • Presence of any pacemaker or defibrillator • Presence of any electronic implants or metal implant in the body (particularly head and neck) • Recent or current pregnancy • Participants who, in the opinion of the investigators, do not understand the information and procedures of the study, or would not be compliant with them. • Participants with current intake of any centrally acting medications (e.g. antidepressants, anticonvulsants, neuropathic pain drugs) or intention of taking new medications in the next 3 months.
Outcome results
None listed