Clinical Research Directory
Browse clinical research sites, groups, and studies.
Brain Network Stimulation for Chronic Low Back Pain.
Sponsor: University of Otago
Summary
This study looks at the non-invasive brain stimulation technique in people with chronic low back pain to see: * How effective non-invasive brain stimulation is at improving pain intensity in people with chronic low back pain? * How safe non-invasive brain stimulation is and what side effects there may be? * What study participants think of the study procedures and of the non-invasive brain stimulation as a treatment technique for chronic low back pain. Participants will be assigned to receive either active brain stimulation group or sham stimulation group randomly. Participants will be required to attend a total of twelve treatment sessions (approximately 1-hour each, three sessions per week, for four consecutive weeks). Assessments will be done at baseline (in the week 0), immediately post-completion of the intervention (in the week 5), and at the follow-up of one-month (in the week 8), three-months (in the week 16) and six-months (in the week 28) post-completion of intervention.
Official title: High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2025-06-12
Completion Date
2028-01
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
High-definition transcranial infraslow grey noise stimulation
HD-tIGNS will be administered three times a week (30 minutes/ session) for a total of 4 weeks (i.e., 12 sessions in total) using a 32-channel transcranial current stimulator. The HD-tIGNS will be used 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 the functional connectivity i.e., phase synchronization of the brain regions of the SN with the SMN and the DMN.
Sham Comparator
The Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics will be used for the sham stimulation group. Similar to the active treatment group, the actisham will be administered three times a week (30 minutes/ session) for a total of 4 weeks (i.e., 12 sessions in total) using a 32-channel transcranial current stimulator.Similar to active group, a total of fifteen circular Ag/AgCl electrodes will be placed on a neoprene head cap following the International 10-10 EEG system to appropriately blind the participant. The electrodes would comprise of four stimulation electrodes (FC1, FC2, FC4, and FCz) and eleven electrodes (C1, C2, C3, C4, F7, F8, FC3, FT7, FPz, Fz, and O2) with zero current.
Locations (1)
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago
Dunedin, Otago, New Zealand