Brain Network Stimulation for Chronic Low Back Pain.

NCT06902233 | Recruiting DMC

• 2 other identifiers: 2024 FULL 2189124-176
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Chronic low back pain; Brain stimulation; Transcranial infraslow grey noise stimulation; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Average pain intensity over the past week measured on a numeric pain rating scale (NPRS) of 0 to 10 (0=No pain to 10=Pain as bad as you can imagine) from the Brief Pain Inventory short form

  The primary endpoint for efficacy assessment of HD-tIGNS will be change in the average pain intensity over the past week from baseline to one-week post completion of treatment.

Secondary Outcomes (22)

• Pain intensity

  Change in the average pain intensity over the past week from baseline to one-month, three-months and six-months post completion of treatment.

• Pain interference

  Change in the pain interference from baseline to one-week, one-month, three-months and six-months post completion of treatment.

• Pain unpleasantness

  Change in the pain unpleasantness from baseline to one-week, one-month, three-months and six-months post completion of treatment.

• Pain Bothersomeness

  Change in the pain bothersomeness from baseline to one-week, one-month, three-months and six-months post completion of treatment.

• Patient global impression of change

  Recorded at one-week, one-month, three-months, and six-months post completion of treatment.

Other Outcomes (1)

• Safety of the intervention

  Recorded at all the intervention sessions and at one-week, one-month, three-months and six-months post-completion of intervention.

Study Arms (2)

High definition transcranial infraslow gray noise stimulation (HD-tIGNS)

EXPERIMENTAL

For the active stimulation group, the HD-tIGNS will be delivered for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, 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.

Device: High-definition transcranial infraslow grey noise stimulation

Sham stimulation

SHAM COMPARATOR

For the sham stimulation group, to create an identical skin sensation to the active stimulation, we will use the Actisham protocol (with FC2 as the itchy electrode) created by the Neuroelectrics. The current will be applied for a 5s ramp up and 5s ramp down at the beginning of each stimulation session, without any current for the remainder of the stimulation period. The sham session will last as long as the HD-tIGNS session to blind the procedure appropriately.

Device: Sham Comparator

Interventions

High-definition transcranial infraslow grey noise stimulation DEVICE

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.

High definition transcranial infraslow gray noise stimulation (HD-tIGNS)

Sham Comparator DEVICE

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.

Also known as: Sham stimulation, Actisham stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥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 ≥5 on Roland-Morris Disability Questionnaire (RMDQ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Otago: lead
• Dunedin School of Medicine, University of Otago, Dunedin, New Zealand: collaborator

Study Sites (1)

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

Dunedin, Otago, 9013, New Zealand

RECRUITING

Related Publications (1)

• Adhia DB, Mani R, Reynolds J, Glue P, Potiki J, Vanneste S, De Ridder D. Functional connectivity-targeted high-definition transcranial infraslow grey noise stimulation for chronic low back pain: protocol for a double-blinded, randomised, controlled clinical trial. BMJ Open. 2025 Aug 24;15(8):e103019. doi: 10.1136/bmjopen-2025-103019.

  PMID: 40850927 DERIVED

Study Officials

• Divya Adhia, Ph.D

  Department of Surgical Sciences, Dunedin School Of Medicine, University of Otago, Dunedin, New Zealand.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Divya Adhia, Ph.D

CONTACT

0064211167594; divya.adhia@otago.ac.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician analysing the data will also be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD will be available after completion of the data collection phase i.e., approximately from January 2028, until 10 years after completion of the study (approximately January 2038).
• Access Criteria: All supporting information will be published in a peer-reviewed journal. The anonymous IPD will be available from the Principal Investigator upon reasonable request for future research.

Locations

NZ (1)