Recruiting NCT06568198
Modulation Effect of tACS on Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Real tACS, Sham tACS.
- Who it may be relevant to
- Registry conditions: Chronic Low-back Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Modulation Effect of Transcranial Alternating Current Stimulation (tACS) on Chronic Low Back Pain
Overview
Investigating the modulation effect of tACS
Detailed description
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
Interventions
- Device Real tACS
α-tACS at a frequency of alpha band at S1 - Device Sham tACS
Sham tACS with no stimulation applied
Primary outcome measures
- Alpha activity at rest [Time frame: Baseline and week 4]
- TC resting state functional connectivity [Time frame: Baseline and week 4]
- Numeric Rating Scale (NRS) for pain intensity [Time frame: Baseline and week 4]
Secondary outcome measures (2)
- Alpha activity during tonic pressure pain [Time frame: Baseline and week 4]
- TC functional connectivity during tonic pain [Time frame: Baseline and week 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Massachusetts General Hospital — Charlestown
Identifiers
NCT: NCT06568198 · 2024p001377 · 5R01NS129059-02