RecruitingPhase 2NCT06568198
Modulation Effect of tACS on Chronic Low Back Pain
Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
Sponsor
Massachusetts General Hospital
Enrollment
80 participants
Start Date
Aug 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Investigating the modulation effect of tACS
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria5
- 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 Criteria12
- 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
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Interventions
DEVICEReal tACS
α-tACS at a frequency of alpha band at S1
DEVICESham tACS
Sham tACS with no stimulation applied
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06568198
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