tACS to reduce chronic low back pain

Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain

The team will try one month of transcranial alternating current stimulation (tACS) to see if it reduces pain in adults with chronic low back pain.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT06568198 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial compares real versus sham transcranial alternating current stimulation (tACS) delivered over one month in adults with chronic low back pain. Participants must have pain for more than six months with at least 4/10 intensity and meet MRI/MEG/EEG safety screening. Outcomes will include self-reported pain intensity (NRS) and neurophysiological or imaging measures collected per protocol. The design uses a sham control to separate true stimulation effects from placebo.

Who should consider this trial

Good fit: Adults 18–60 with chronic low back pain (>6 months), average pain ≥4/10, able to read at least 10th-grade English and eligible for MRI/MEG/EEG screening are the ideal candidates.

Not a fit: Patients with specific structural causes of back pain (for example cancer, fracture, or spinal stenosis), prior complicated back surgery or medicolegal issues, planned surgery during the study, significant cardiac/respiratory/neurologic comorbidity, or contraindications to MRI are unlikely to benefit or to be eligible.

Why it matters

Potential benefit: If successful, tACS could provide a noninvasive option to reduce chronic low back pain and potentially reduce reliance on medications or invasive procedures.

How similar studies have performed: Related noninvasive brain stimulation techniques such as tDCS and rTMS have shown modest pain reductions in small studies, but tACS is less studied and evidence for its effectiveness in chronic low back pain remains limited.

Eligibility criteria

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:

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

Where this trial is running

Charlestown, Massachusetts

• Massachusetts General Hospital — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Jian Kong

Conditions Chronic Low-back Pain