30 Participants NeededMy employer runs this trial

Brain Stimulation for Chronic Pain

RG
Overseen ByRaghavan Gopalakrishnan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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 it aims to answer are:

Does tACS alter the way chronic pain patients confront pain in terms of avoidance behavior? How does tACS impact brain signals related to pain avoidance behavior?

Participants will:

1. fill out self-administered questionnaires asking about their medication use, personality and temperament, mood, including anxiety and depression, current pain level, and any disability you have due to your pain.

2. perform of a pain avoidance task before, during and after 'real' tACS or 'sham' tACS. They may also be asked to stay quiet before, during and after tACS. During this period, we will scan the brain using a neuroimaging device called Magnetoencephalography (MEG). Additionally, Electroencephalography (EEG) brain signals will also be collected using electrodes affixed to the scalp. We may also measure Skin conductance response (SCR) and electrocardiography (EKG) using electrodes affixed to the skin.

3. also get a T1 MRI if they do not have an implanted SCS, DRG, intrathecal pump, or other similar device that are not MRI compatible.

Are You a Good Fit for This Trial?

This trial is for adults with chronic pain from Complex Regional Pain Syndrome. People cannot join if they have implanted medical devices that are not safe for MRI scans, such as certain pain pumps or stimulators.

Inclusion Criteria

Absence of co-occurring severe psychiatric disorders with PHQ-9 <19 and/or GAD-7 <14
I have CRPS causing pain in one or both legs.
I have increased pain or sensitivity to touch.
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Exclusion Criteria

I am currently receiving neurostimulation therapy like spinal cord stimulation.
PHQ-9 >19 and/or GAD-7 >14 indicating severe depression or anxiety
My average daily pain has been less than 5 out of 10 for the past month.
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What Are the Treatments Tested in This Trial?

Interventions

  • transcranial alternating current stimulation (tACS)

Trial Overview

The study tests whether a gentle brain stimulation method called tACS can change how people with chronic pain avoid activities due to fear of pain. Participants will get either real tACS or a fake (sham) version in a randomized design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: alpha frequency tACSExperimental Treatment1 Intervention
Group II: gamma frequency tACSActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Recruited
677,000+