Modulation Effect of tACS on Chronic Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Device: Real tACS; Device: Sham tACS

• Registration Number: NCT06568198
• Lead Sponsor: Massachusetts General Hospital

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

Study Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Study Start: 2025-03
• Primary Completion: 2028-02
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real tACS	Real tACS	-
Sham tACS	Sham tACS	-

Primary Outcome Measures

Name	Time	Method
thalamo-sensory-cortex connectivity	about one month, data will be collected at baseline and after one month treatment	Functional connectivity between the thalamus and sensory-motor cortex as measured by Functional magnetic resonance imaging (fMRI) and Magnetoencephalography (MEG) using MRI scanner and MEG device

Secondary Outcome Measures

Name	Time	Method
Low back pain intensity	about one month, data will be collected at baseline and after one month treatment	As measured by pain visual analog scale (0-10)