NCT06902233

Brain Network Stimulation for Chronic Low Back Pain.

High-definition Transcranial Infraslow Gray Noise Stimulation for Treatment of Chronic Low Back Pain: A Double-blinded Randomised Controlled Clinical Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: University of Otago · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain (CLBP)

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-06-12
• Primary completion: 2027-06-01
• Completion: 2028-01-01
• First posted: 2025-03-30
• Last updated: 2025-07-31

Locations

1 site across 1 country: New Zealand