Chronic Low-back PainNCT06025201
Detection of EEG-Based Biomarkers of Chronic Low Back Pain
A study testing Resting State EEG, Picture Viewing EEG and Stop Signal EEG in people with Chronic Low-back Pain and Healthy, run by Stanford University at 1 site in United States.
Trial summary
Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain, Healthy
- What is being tested?
- Resting State EEG, Picture Viewing EEG and Stop Signal EEG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current diagnosis of Chronic Low Back Pain
Who cannot join
- Current diagnosis of cancer
- Severe psychiatric conditions
- Pending personal litigation relating to an injury or receiving workers' compensation benefits
- Being a non-English speaker.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford's Systems and Neuroscience Pain Lab
Palo Alto, California, 94304
Omar Altirkawi, 650-724-8426, omar97@stanford.edu
About this study
Official title: Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain
Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Biomarkers that predict symptom progression in CLBP support precision-based treatments and ultimately aid in reducing suffering. Longitudinal brain-based resting-state neuroimaging of patients with CLBP has revealed neural networks that predict pain chronification and its symptom progression. Although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. Measurements of different neural systems may provide additional benefits with better predictive power.
Emotional and cognitive dysfunction is common in CLBP, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. Likewise, improvements in electroencephalogram (EEG) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging [MRI] and functional MRI), such as high cost and limited accessibility. Using longitudinal EEG, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with CLBP, which will aid in predicting symptom progression in CLBP. Through this award, the investigators will use modern EEG source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. A 5-month follow up will also be used to only assess patient reported outcomes. In Aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with CLPB and age/sex-matched controls. In Aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. In Aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of CLBP using EEG features from resting-state, emotional, and cognitive networks.
- Conditions
- Chronic Low-back Pain, Healthy
- Being tested
- Resting State EEG, Picture Viewing EEG, Stop Signal EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting State EEGBehavioural
During this intervention, participants will be asked to not think about anything in particular while EEG is recorded. Resting state will be conducted with either the participants having their eyes open, or eyes closed.
Picture Viewing EEGBehavioural
During this intervention, participants will view emotionally charged pictures for a short period of time. Afterwards, participants will be asked to rate their emotional reactions to the pictures. EEG will be recorded during this intervention.
Stop Signal EEGBehavioural
During this intervention, participants will be asked to respond quickly to a visual stimulus with a button press. At times, participants will be asked to inhibit their responses. EEG will be recorded during this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants will complete all interventions Receives: Behavioral: Resting State EEG; Behavioral: Picture Viewing EEG; Behavioral: Stop Signal EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average
Within subjects change in pain intensity from baseline to each follow up point. Pain intensity measures are 0-10 range with larger numbers indicating more pain
Measured: Baseline, 1-month, 2-month and 5-month follow-ups
EEG resting state functional connectivity changes from baseline
Within subjects change in resting state functional connectivity from baseline to each follow up point.
Measured: Baseline, 1-month and 2-month follow-ups
EEG late positive potential changes from baseline
Within subjects change in late positive potential from baseline to each follow up point.
Measured: Baseline, 1-month and 2-month follow-ups
EEG error related negativity changes from baseline
Within subjects change in error related negativity from baseline to each follow up point.
Measured: Baseline, 1-month and 2-month follow-ups
Secondary outcomes (1)
Neuropsychological changes from baseline as assessed by the NIH toolbox
Within subjects change in metrics of fluid and crystallized intelligence from baseline to each follow up point
Measured: Baseline, 1-month and 2-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start15 Dec 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete all interventions.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Edward Lannon, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025201
- Sponsor's protocol ID
- 71778
- Other IDs
- 1K23AR083171-01
- Status last verified
- May 2026
- First submitted
- 24 Aug 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will support requests for data sharing in a timely manner. Prior to sharing data, the data will be redacted of all personal identifiers to prevent subject identification.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06025201
- Acronym / sponsor ID
- 71778
- Conditions
- Chronic Low-back Pain, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Biomarkers that predict symptom progression in CLBP support precision-based treatments and ultimately aid in reducing suffering. Longitudinal brain-based resting-state neuroimaging of patients with CLBP has revealed neural networks that predict pain chronification and its symptom progression. Although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. Measurements of different neural systems may provide additional benefits with better predictive power.
Emotional and cognitive dysfunction is common in CLBP, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. Likewise, improvements in electroencephalogram (EEG) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging [MRI] and functional MRI), such as high cost and limited accessibility. Using longitudinal EEG, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with CLBP, which will aid in predicting symptom progression in CLBP. Through this award, the investigators will use modern EEG source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. A 5-month follow up will also be used to only assess patient reported outcomes. In Aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with CLPB and age/sex-matched controls. In Aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. In Aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of CLBP using EEG features from resting-state, emotional, and cognitive networks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete all interventions.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Resting State EEG, Behavioral: Picture Viewing EEG, Behavioral: Stop Signal EEGAll participants will complete all interventions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current diagnosis of Chronic Low Back Pain
Key exclusion criteria (4 listed)
- Current diagnosis of cancer
- Severe psychiatric conditions
- Pending personal litigation relating to an injury or receiving workers' compensation benefits
- Being a non-English speaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting State EEGDuring this intervention, participants will be asked to not think about anything in particular while EEG is recorded. Resting state will be conducted with either the participants having their eyes open, or eyes closed. | Behavioural | Single Arm |
| Picture Viewing EEGDuring this intervention, participants will view emotionally charged pictures for a short period of time. Afterwards, participants will be asked to rate their emotional reactions to the pictures. EEG will be recorded during this intervention. | Behavioural | Single Arm |
| Stop Signal EEGDuring this intervention, participants will be asked to respond quickly to a visual stimulus with a button press. At times, participants will be asked to inhibit their responses. EEG will be recorded during this intervention. | Behavioural | Single Arm |
Primary outcome
Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average
Time frame: Baseline, 1-month, 2-month and 5-month follow-ups
Within subjects change in pain intensity from baseline to each follow up point. Pain intensity measures are 0-10 range with larger numbers indicating more pain
EEG resting state functional connectivity changes from baseline
Time frame: Baseline, 1-month and 2-month follow-ups
Within subjects change in resting state functional connectivity from baseline to each follow up point.
EEG late positive potential changes from baseline
Time frame: Baseline, 1-month and 2-month follow-ups
Within subjects change in late positive potential from baseline to each follow up point.
EEG error related negativity changes from baseline
Time frame: Baseline, 1-month and 2-month follow-ups
Within subjects change in error related negativity from baseline to each follow up point.
1 secondary outcome
Neuropsychological changes from baseline as assessed by the NIH toolbox
Time frame: Baseline, 1-month and 2-month follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. The investigators will support requests for data sharing in a timely manner. Prior to sharing data, the data will be redacted of all personal identifiers to prevent subject identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting State EEG, Picture Viewing EEG and Stop Signal EEG in people with Chronic Low-back Pain and Healthy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Altirkawi (650-724-8426, omar97@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average (time frame: Baseline, 1-month, 2-month and 5-month follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.