Health TrialsbyHealthPanel

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

ConditionComplex Regional Pain Syndrome (CRPS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcranial alternating current stimulation (tACS)

    Device

    Real tACS will stimulate the brain in the individual alpha frequency (8-12 Hz) measured from baseline MEG

  • transcranial alternating current stimulation (tACS)

    Device

    active control tACS will stimulate the brain at 40Hz

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: alpha frequency tACSExperimental treatment 1 intervention
Group B: gamma frequency tACSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

magnitude of alpha frequency band power

measured using MEG/EEG from resting-state and during the performance of pain avoidance task. The MEG/EEG neural signals will be transformed to frequency domain to measure the magnitude of power in the alpha band.

Time frame
Periprocedural

Secondary outcomes

1

standard deviation in R-R length

standard deviation in R-R length (SDNN), a measure of heart rate variability from RR interval tachogram derived from EKG.

Time frame
Periprocedural
2

number of spontaneous skin conductance fluctuations

number of spontaneous skin conductance fluctuations will be measured from galvanic skin conductance response time-series data.

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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