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Effects of Non-invasive Brain Stimulation on Pain Avoidance Behavior in Chronic Pain Patients

RecruitingNAAges 18 Years - anyAllThe Cleveland Clinic
NCT07791966 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pain avoidance helps with survival. However, chronic pain patients often avoid valued life activities fearing onset or exacerbation of pain. Hence, pain avoidance no longer protects, but reduces quality of life. The goal of this clinical trial is to learn if non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) impact pain avoidance behavior in chronic pain patients. tACS is a way to gently stimulate the brain using a small, portable device. It sends an extremely weak, continuous alternating current through the scalp. Participants will either get real tACS or a fake (sham) version. Real tACS will stimulate the brain in the alpha frequency (8-12 Hz) which has been found to influence pain avoidance behavior, whereas sham tACS will stimulate the brain in a different frequency that is not known to influence avoidance behavior. The main questions

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 years or older * Diagnosed with Complex Regional Pain Syndrome (CRPS) Type I or II, based on Budapest criteria * 6 months or more of medically refractory severe pain * Average daily pain for past 30 days \>= 5 on 0-10 scale * Presence of allodynia and/or hyperalgesia * Lower extremity CRPS: bilateral or unilateral pain * Not concurrently treated with neurostimulation therapies such as spinal cord stimulators (SCS) * Absence of co-occurring severe psychiatric disorders (PHQ-9\<19 and/or GAD-7\<14) Exclusion Criteria: * Age under 18 years, pregnant women of any age * Any co-occurring pain diagnosis that might confound with allodynia/hyperalgesia resulting from CRPS reflecting a malfunction in sensory processing within the CNS. * Less than six months of medically refractory pain * Average daily pain for past 30 days \<5 on 0-10 scale * Absence of allodynia and/or hyperalgesia * Concurrent neurostimulation therapies such as SCS * Severe disorders or conditions (e.g., cardiovascular, liver issues), terminal illness * PHQ-9\>19 and/or GAD-7\>14 (severe depression/anxiety)
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What it tests

  • transcranial alternating current stimulation (tACS)
  • transcranial alternating current stimulation (tACS)
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Where

1 site
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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