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RecruitingNCT06568198Updated Mar 16, 2026

Modulation Effect of tACS on Chronic Low Back Pain

A Phase 2 interventional study of Real tACS and Sham tACS in Chronic Low-back Pain, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Basic science

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Low-back Pain
03

In context

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Volunteers 18-60 years of age
  2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
  3. At least 4/10 clinical pain on the 0-10 LBP NRS
  4. 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
  5. Meeting the MRI / MEG / EEG screening criteria

Exclusion criteria

Exclusion Criteria:

  1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
  2. Complicated back problems (eg, prior back surgery, medicolegal issues)
  3. The intent to undergo surgery during the time of involvement in the study
  4. 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)
  5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
  6. Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases
  7. Pregnant or lactating
  8. 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)
  9. Active substance abuse disorders (based on subject self-report and drug test)
  10. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
  11. Any medical conditions, such as peripheral neuropathy, that could affect the results of QST
  12. Current use of psychotropic medication
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    real tACS

    Device: Real tACS

  • Sham comparator
    Sham tACS

    Device: Sham tACS

Interventions

  • DeviceReal tACS

    α-tACS at a frequency of alpha band at S1

  • DeviceSham tACS

    Sham tACS with no stimulation applied

06

What researchers measure

Primary outcomes

  1. Alpha activity at rest

    EEG/MEG data will be collected to measure alpha activity.

    Time frame: Baseline and week 4

  2. TC resting state functional connectivity

    fMRI data will be collected to measure resting state functional connectivity.

    Time frame: Baseline and week 4

  3. 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.

    Time frame: Baseline and week 4

Secondary outcomes

  1. 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.

    Time frame: Baseline and week 4

  2. 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.

    Time frame: Baseline and week 4

07

Study locations

1 of 1 sites recruiting
  • Massachusetts General Hospital
    Charlestown, Massachusetts 02129, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06568198
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Jian Kong (Principal investigator, Massachusetts General Hospital) — Principal investigator
First posted
Aug 23, 2024
Start date
Aug 25, 2025
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Mar 16, 2026

Study contacts

JIAN KONG
Contact
jkong2@mgh.harvard.edu
6179620978

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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