ClinicalTrials.gg
RecruitingNCT07791966Updated Aug 28, 2026

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

An interventional study of transcranial alternating current stimulation (tACS) and transcranial alternating current stimulation (tACS) in Complex Regional Pain Syndrome (CRPS), sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.

Planned enrollment
34th of 67
30 · median 30
Started
2026
with 5 others
No phase
36 of 88
10 open now
Primary completion
2028-08
later than 17 of 21 live
Registered
86th of 88
by date
Lead sponsor
4 of 88
The Cleveland Clinic

Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 34th largest by planned enrollment of the 67 interventional ones that give a count, is one of 6 that started in 2026, is one of 36 with no phase, reaches primary completion later than 17 of the 21 other live ones, and was the 86th registered.

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.

Browse Complex Regional Pain Syndromes studies →

Open to participants now

20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 88 studies in Complex Regional Pain Syndromes with a site in United States, or all of them as a file.
02

Study summary

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.
03

Conditions studied

  • Complex Regional Pain Syndrome (CRPS)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    alpha frequency tACS

    Device: transcranial alternating current stimulation (tACS)

  • Active comparator
    gamma frequency tACS

    Device: transcranial alternating current stimulation (tACS)

Interventions

  • Devicetranscranial alternating current stimulation (tACS)

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

  • Devicetranscranial alternating current stimulation (tACS)

    active control tACS will stimulate the brain at 40Hz

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Gopalakrishnan R, Sonneborn C, Baillet S, Machado AG, Wager TD, Roy M. Neurophysiological encoding of aversive prediction errors. Pain. 2025 Dec 1;166(12):e732-e745. doi: 10.1097/j.pain.0000000000003712. Epub 2025 Jul 16. PubMed 40668023 ↗
  • Malan NS, Baillet S, Tankha P, Roy M, Gopalakrishnan R. Altered cortical alpha modulations and connectivity in complex regional pain syndrome. J Pain. 2026 Feb;39:105595. doi: 10.1016/j.jpain.2025.105595. Epub 2025 Nov 7. PubMed 41207412 ↗
  • Gopalakrishnan R, Malan NS, Sonneborn C, Hogue O, Tankha P, Baillet S, Roy M. Mechanisms Underlying Pain Avoidance in Complex Regional Pain Syndrome. Eur J Pain. 2026 Aug;30(7):e70339. doi: 10.1002/ejp.70339. PubMed 42504856 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in publications, along with relevant study documentation and analytic code, may be shared with qualified researchers upon reasonable request to the study investigators. Data will be available following publication of the primary study results, subject to applicable institutional policies, informed consent provisions, and execution of an appropriate data use agreement.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Aug 2028, 22 months later.

Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 22 months is close to that.

Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2026
First posted
Aug 28, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Aug 31, 2028
CompletionEst.
Dec 2028
Last update
Aug 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07791966
Responsible party
Raghavan Gopalakrishnan (Associate Staff, The Cleveland Clinic) — Principal investigator
First posted
Aug 28, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Aug 31, 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Raghavan Gopalakrishnan
Contact
gopalar@ccf.org
2164459322

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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