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NCT Number: NCT06568198

Modulation Effect of tACS on Chronic Low Back Pain

Investigating the modulation effect of tACS

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Daniel Lee

CONTACT

[email protected]

617-726-5004

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Real tACS

Device

α-tACS at a frequency of alpha band at S1

Sham tACS

Device

Sham tACS with no stimulation applied

Primary outcomes

  1. Alpha activity at rest

    Time frame: Baseline and week 4

    EEG/MEG data will be collected to measure alpha activity.

  2. TC resting state functional connectivity

    Time frame: Baseline and week 4

    fMRI data will be collected to measure resting state functional connectivity.

  3. Numeric Rating Scale (NRS) for pain intensity

    Time frame: Baseline and week 4

    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.

Secondary outcomes

  1. Alpha activity during tonic pressure pain

    Time frame: Baseline and week 4

    EEG/MEG data will be collected during administration of tonic pressure pain to measure alpha activity changes before and after tACS.

  2. TC functional connectivity during tonic pain

    Time frame: Baseline and week 4

    fMRI data will be collected during administration of tonic pressure pain to measure functional connectivity changes before and after tACS.

Study contacts

Contact information is provided by the study sponsor or research team.

JIAN KONG

CONTACT

[email protected]

6179620978

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 23, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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