Modulation Effect of tACS on Chronic Low Back Pain

NCT ID: NCT06568198

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2028-02-28

Brief Summary

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Investigating the modulation effect of tACS

Detailed Description

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

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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real tACS

Group Type EXPERIMENTAL

Real tACS

Intervention Type DEVICE

α-tACS at a frequency of alpha band at S1

Sham tACS

Group Type SHAM_COMPARATOR

Sham tACS

Intervention Type DEVICE

Sham tACS with no stimulation applied

Interventions

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Real tACS

α-tACS at a frequency of alpha band at S1

Intervention Type DEVICE

Sham tACS

Sham tACS with no stimulation applied

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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JIAN KONG

Role: CONTACT

6179620978

Facility Contacts

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Daniel Lee

Role: primary

617-726-5004

Other Identifiers

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5R01NS129059-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024p001377

Identifier Type: -

Identifier Source: org_study_id

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