Non-invasive brain stimulation to see if it changes pain avoidance in CRPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses transcranial alternating current stimulation (tACS) to explore its effect on pain avoidance behavior in adults with CRPS. Participants are randomized to receive real alpha-frequency tACS (8-12 Hz) or a sham control, with the goal of determining if brain stimulation can modify avoidance of valued activities due to pain. The trial focuses on individuals with medically refractory CRPS for at least six months and moderate to severe daily pain, excluding those with concurrent neurostimulation devices or major psychiatric conditions. Primary outcomes examine changes in avoidance behavior, while secondary outcomes may include pain intensity and functional measures. The Cleveland Clinic leads the study with NCCIH collaboration, enrolling participants at the Cleveland Clinic site in Ohio.

Why it matters

Who can join: the full rules

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)

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Raghavan Gopalakrishnan
• Email: gopalar@ccf.org
• Phone: 2164459322

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.