Modulation Effect of tACS on Chronic Low Back Pain

NCT06568198 | Recruiting Phase 2 DMC

• 2 other identifiers: 2024p0013775R01NS129059-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the modulation effect of tACS

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Alpha activity during tonic pressure pain

  Baseline and week 4

• TC functional connectivity during tonic pain

  Baseline and week 4

Study Arms (2)

real tACS

EXPERIMENTAL

Device: Real tACS

Sham tACS

SHAM COMPARATOR

Device: Sham tACS

Interventions

Sham tACS DEVICE

Sham tACS with no stimulation applied

Sham tACS

Real tACS DEVICE

α-tACS at a frequency of alpha band at S1

real tACS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

Central Study Contacts

JIAN KONG

CONTACT

6179620978; jkong2@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 23, 2024
• Study Start: August 25, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)