Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000549426
Ethics application status
Approved
Date submitted
12/05/2025
Date registered
30/05/2025
Date last updated
30/05/2025
Date data sharing statement initially provided
30/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring effect of brain network stimulation on brain activity and connectivity in individuals with chronic low back pain.
Scientific title
Effect of high definition transcranial infraslow gray noise stimulation (HD-tIGNS) on cortical activity and functional connectivity in individuals with chronic low back pain: A pilot randomised placebo-controlled study.
Secondary ID [1] 314428 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of the larger randomized controlled trial investigating the efficacy of the HD-tIGNS compared to sham stimulation, as measured by the change in average pain intensity from baseline to one-week post completion of intervention in people with CLBP. The larger trial is registered in clinical trials registry (Ref: NCT06902233).

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 337444 0
Condition category
Condition code
Musculoskeletal 333816 333816 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)]
Intervention code [1] 331036 0
Treatment: Devices
Comparator / control treatment
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. Similar to active group, the actisham will be delivered for a single session of 30min, with the current being applied for a 5s ramp up and 5s ramp down at the beginning of the session, without any current for the remainder of the stimulation period. The maximum current strength per electrode will be 0.5 mA. The sham session will thus last as long as the HD-tIGNS session to blind the procedure appropriately.

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.
Control group
Placebo

Outcomes
Primary outcome [1] 341424 0
Resting state Electroencephalography
Timepoint [1] 341424 0
Recorded at baseline and immediately post completion of intervention session.
Primary outcome [2] 341425 0
Safety of the intervention
Timepoint [2] 341425 0
Recorded one-day post completion of intervention session
Primary outcome [3] 341537 0
Resting state Electroencephalography
Timepoint [3] 341537 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [1] 447456 0
Resting state Electroencephalography (Primary outcome)
Timepoint [1] 447456 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [2] 447471 0
Resting state Electroencephalography (Primary outcome)
Timepoint [2] 447471 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [3] 447472 0
Resting state Electroencephalography (Primary outcome)
Timepoint [3] 447472 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [4] 447473 0
Resting state Electroencephalography (Primary outcome)
Timepoint [4] 447473 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [5] 447476 0
Resting state Electroencephalography (Primary outcome)
Timepoint [5] 447476 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [6] 447866 0
Resting state Electroencephalography (Primary outcome)
Timepoint [6] 447866 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [7] 447867 0
Resting state Electroencephalography (Primary outcome)
Timepoint [7] 447867 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [8] 447870 0
Resting state Electroencephalography (Primary outcome)
Timepoint [8] 447870 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [9] 447871 0
Resting state Electroencephalography (Primary outcome)
Timepoint [9] 447871 0
Recorded at baseline and immediately post completion of intervention session.
Secondary outcome [10] 447872 0
Average pain in past 24 hours
Timepoint [10] 447872 0
Baseline, and 1 day post-intervention
Secondary outcome [11] 447873 0
Worst pain in the past 24 hours
Timepoint [11] 447873 0
Baseline, and 1 day post-intervention
Secondary outcome [12] 447874 0
Pain unpleasantness in the past 24 hours
Timepoint [12] 447874 0
Baseline, and 1 day post-intervention
Secondary outcome [13] 447875 0
Pain bothersomeness in the past 24 hours
Timepoint [13] 447875 0
Baseline, and 1 day post-intervention
Secondary outcome [14] 447876 0
Current pain
Timepoint [14] 447876 0
Baseline, and 1 day post-intervention

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/06/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
20/12/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 27062 0
New Zealand
State/province [1] 27062 0
Otago

Funding & Sponsors
Funding source category [1] 318955 0
Government body
Name [1] 318955 0
Health Research Council
Country [1] 318955 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321423 0
None
Name [1] 321423 0
Address [1] 321423 0
Country [1] 321423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317566 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317566 0
Ethics committee country [1] 317566 0
New Zealand
Date submitted for ethics approval [1] 317566 0
22/11/2024
Approval date [1] 317566 0
24/02/2025
Ethics approval number [1] 317566 0
2024 FULL 21891

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141446 0
Dr Divya Bharatkumar Adhia
Address 141446 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago. PO Box 56. Dunedin 9054, New Zealand
Country 141446 0
New Zealand
Phone 141446 0
+64 211167594
Fax 141446 0
Email 141446 0
[email protected]
Contact person for public queries
Name 141447 0
Divya Bharatkumar Adhia
Address 141447 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago. PO Box 56. Dunedin 9054, New Zealand
Country 141447 0
New Zealand
Phone 141447 0
+64 211167594
Fax 141447 0
Email 141447 0
[email protected]
Contact person for scientific queries
Name 141448 0
Divya Bharatkumar Adhia
Address 141448 0
Department of Surgical Sciences, Dunedin School of Medicine, University of Otago. PO Box 56. Dunedin 9054, New Zealand
Country 141448 0
New Zealand
Phone 141448 0
+64 211167594
Fax 141448 0
Email 141448 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.