Modulation Effect of tACS on Chronic Low Back Pain

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

Investigating the modulation effect of tACS

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Device: Real tACS; Device: Sham tACS

Detailed Description

Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JIAN KONG; Phone Number: 6179620978; Email: jkong2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Daniel Lee; Phone Number: 617-726-5004; Email: dlee92@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham tACS	Device: Sham tACS; Sham tACS with no stimulation applied
Experimental: real tACS	Device: Real tACS; α-tACS at a frequency of alpha band at S1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha activity at rest	EEG/MEG data will be collected to measure alpha activity.	Baseline and week 4
TC resting state functional connectivity	fMRI data will be collected to measure resting state functional connectivity.	Baseline and week 4
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.	Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and week 4
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.	Baseline and week 4

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2024p001377; 5R01NS129059-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No