Status:
RECRUITING
Modulation Effect of tACS on Chronic Low Back Pain
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Investigating the modulation effect of tACS
Detailed Description
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06568198
Start Date
May 29 2025
End Date
March 1 2028
Last Update
January 6 2026
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129