Chronic Low-back PainPhase 2NCT06568198
Modulation Effect of tACS on Chronic Low Back Pain
A Phase 2 study testing Real tACS in people with Chronic Low-back Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Investigating the modulation effect of tACS Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Real tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 28 Feb 2028
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteers 18-60 years of age
- Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
- At least 4/10 clinical pain on the 0-10 LBP NRS
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
- Meeting the MRI / MEG / EEG screening criteria
Who cannot join
- Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
- Complicated back problems (eg, prior back surgery, medicolegal issues)
- The intent to undergo surgery during the time of involvement in the study
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
- Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases
Show all 12Show fewer
- Pregnant or lactating
- Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
- Active substance abuse disorders (based on subject self-report and drug test)
- Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
- Any medical conditions, such as peripheral neuropathy, that could affect the results of QST
- Current use of psychotropic medication
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
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Daniel Lee, 617-726-5004, dlee92@mgh.harvard.edu
About this study
Official title: Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
Investigating the modulation effect of tACS
Read the detailed description
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
- Conditions
- Chronic Low-back Pain
- Being tested
- Real tACS, Sham tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tACSDevice
α-tACS at a frequency of alpha band at S1
Sham tACSDevice
Sham tACS with no stimulation applied
| Study group | Role | What they receive |
|---|---|---|
| real tACS | Experimental | Not described Receives: Device: Real tACS |
| Sham tACS | Sham comparator | Not described Receives: Device: Sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha activity at rest
EEG/MEG data will be collected to measure alpha activity.
Measured: Baseline and week 4
TC resting state functional connectivity
fMRI data will be collected to measure resting state functional connectivity.
Measured: Baseline and week 4
Numeric Rating Scale (NRS) for pain intensity
The NRS is a uni-dimensional measure of pain intensity that uses an 11-point numeric scale. We will use it to measure the average low back pain intensity in the past week.
Measured: Baseline and week 4
Secondary outcomes (2)
Alpha activity during tonic pressure pain
EEG/MEG data will be collected during administration of tonic pressure pain to measure alpha activity changes before and after tACS.
Measured: Baseline and week 4
TC functional connectivity during tonic pain
fMRI data will be collected during administration of tonic pressure pain to measure functional connectivity changes before and after tACS.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start25 Aug 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion28 Feb 2028 (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 Massachusetts General HospitalThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568198
- Sponsor's protocol ID
- 2024p001377
- Other IDs
- 5R01NS129059-02
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06568198
- Acronym / sponsor ID
- 2024p001377
- Conditions
- Chronic Low-back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 23 Aug 2024 (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.
Investigating the modulation effect of tACS
Detailed description
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tACS | Experimental | Device: Real tACS |
| Sham tACS | Sham comparator | Device: Sham tACS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteers 18-60 years of age
- Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
- At least 4/10 clinical pain on the 0-10 LBP NRS
- At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
- Meeting the MRI / MEG / EEG screening criteria
Key exclusion criteria (12 listed)
- Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
- Complicated back problems (eg, prior back surgery, medicolegal issues)
- The intent to undergo surgery during the time of involvement in the study
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
- Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
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 |
|---|---|---|
| Real tACSα-tACS at a frequency of alpha band at S1 | Device | real tACS |
| Sham tACSSham tACS with no stimulation applied | Device | Sham tACS |
Primary outcome
Alpha activity at rest
Time frame: Baseline and week 4
EEG/MEG data will be collected to measure alpha activity.
TC resting state functional connectivity
Time frame: Baseline and week 4
fMRI data will be collected to measure resting state functional connectivity.
Numeric Rating Scale (NRS) for pain intensity
Time frame: Baseline and week 4
The NRS is a uni-dimensional measure of pain intensity that uses an 11-point numeric scale. We will use it to measure the average low back pain intensity in the past week.
2 secondary outcomes
Alpha activity during tonic pressure pain
Time frame: Baseline and week 4
TC functional connectivity during tonic pain
Time frame: Baseline and week 4
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 16 Mar 2026.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing Real tACS in people with Chronic Low-back Pain, run by Massachusetts General Hospital 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 5 inclusion and 12 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 16 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 JIAN KONG (6179620978, jkong2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha activity at rest (time frame: Baseline and week 4). The study lists 3 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 16 Mar 2026.