None listed
Conditions
Brief summary
In people with chronic low back pain (CLBP), increased functional connectivity of the brain regions of the salience network (SN) with the brain regions of the default mode network (DMN) and the somatomotor network (SMN) have been noted in the infraslow frequency spectrum (less than and equal to 0.1 Hz). Further, higher SN-SMN and SN-DMN functional connectivity are associated with higher pain experience and disability. A novel approach disrupting the functional connectivity between the brain networks (vs activity in individual brain regions) could result in better clinical outcomes. In this study, we will test if a non-invasive brain stimulation technique (i.e., HD-tIGNS) can decrease the functional connectivity strength between the key nodes of the targeted cortical networks (SN and the DMN and SMN) in the infraslow frequency spectrum (0.1 Hz).
Interventions
For the active stimulation group, the high definition transcranial infraslow gray noise stimulation (HD-tIGNS) will be delivered by a researcher with experience in delivering neuromodulation techniques, for a single session of 30min, with 60s ramp up and ramp down at the beginning and end, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum t
For the active stimulation group, the high definition transcranial infraslow gray noise stimulation (HD-tIGNS) will be delivered by a researcher with experience in delivering neuromodulation techniques, for a single session of 30min, with 60s ramp up and ramp down at the beginning and end, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA. Adherence of the intervention (i.e., duration of stimulation completed) will be recorded by the treating researcher. The HD-tIGNS will be delivered using a 32-channel Starstim transcranial electrical stimulator to alter the functional connectivity strength between the three cortical networks [namely the salience network (SN), the default mode network (DMN) and the somatomotor network (SMN)] in the infraslow frequency spectrum (0.1 Hz). A total of fifteen circular Ag/AgCl electrodes [eleven stimulation electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) and four electrodes with zero current (FC1, FC2, FC4, and FCz)] will be placed on a neoprene head cap following the International 10-10 EEG system. The optimal montages has been created using the Stimweaver optimization software by the Neuroelectrics company, to specifically decrease/disrupt the functional connectivity i.e., phase synchronization of the brain regions of the SN with the SMN and the DMN [i.e., dorsal anterior cingulate cortex (dACC), Insula (INS), Somatosensory cortex (SSC), motor cortex (MC), pregenual anterior cingulate cortex (pgACC)]
Sponsors
University of Otago
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 primary chronic low back pain (CLBP) will be eligible to participate. To be included in the study, participants must meet all the following inclusion criteria: - Capable of understanding the study information and able to sign the informed consent form - Age between 18 to 75 years on the day of screening - Pain in the lower back (region between 12th rib and gluteal fold) with or without accompanying leg pain that occurs for at least half the days in the last six months - An average pain intensity of greater than or equal to 4 on the 11-point NPRS (0=No pain to 10=Pain as bad as you can imagine) in the week prior to enrolment - A disability score of greater than or equal to 5 on Roland–Morris Disability Questionnaire (RMDQ).
Exclusion criteria
- Known or suspected serious spinal pathology (fracture; lumbar canal stenosis, malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder) - Suspected or confirmed pregnancy or less than six months post-partum - Inflammatory disorders - Auto-immune conditions - Recent soft tissue injuries of the back in the last 3 months - Recent steroid injections to the back in the past 3 months - Recent spinal surgery in the past 12 months or scheduled/waiting for any major surgical procedures during the treatment or follow-up period or underwent rhizotomy or any neurosurgical procedures - History of neurological conditions, or psychiatric disorders (except depression and anxiety disorders) - History of cancer, or currently receiving/scheduled for receiving therapy for cancer - Cognitive impairments (dementia, Alzheimer’s disease; indicated by a total score of 24 or below on Mini-Mental State Examination) - Alcohol or substance abuse - History of epilepsy or seizures - Presence of any electronic implants (e.g., pacemaker), metal implant in the body (particularly head and neck), or spinal cord stimulator.
Outcome results
None listed