Brain Network Stimulation for Chronic Low Back Pain.

NARecruitingINTERVENTIONAL
Enrollment

164

Participants

Timeline

Start Date

June 12, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

January 31, 2028

Conditions
Chronic Low Back Pain (CLBP)
Interventions
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.

Trial Locations (1)

9013

RECRUITING

Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin

All Listed Sponsors
collaborator

Dunedin School of Medicine, University of Otago, Dunedin, New Zealand

UNKNOWN

lead

University of Otago

OTHER

NCT06902233 - Brain Network Stimulation for Chronic Low Back Pain. | Biotech Hunter | Biotech Hunter