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

26. august 2026 opdateret af: Raghavan Gopalakrishnan, The Cleveland Clinic

Alpha tACS and Pain Avoidance Behavior in Chronic Pain Patients

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Raghavan Gopalakrishnan
  • Telefonnummer: 2164459322
  • E-mail: gopalar@ccf.org

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Rekruttering
        • Cleveland Clinic
        • Kontakt:
          • Raghavan Gopalakrishnan
          • Telefonnummer: 800-223-2273
          • E-mail: gopalar@ccf.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: alpha frequency tACS
Enhed: transcranial alternating current stimulation (tACS)
Real tACS will stimulate the brain in the individual alpha frequency (8-12 Hz) measured from baseline MEG
Enhed: transcranial alternating current stimulation (tACS)
active control tACS will stimulate the brain at 40Hz
Aktiv komparator: gamma frequency tACS
Enhed: transcranial alternating current stimulation (tACS)
Real tACS will stimulate the brain in the individual alpha frequency (8-12 Hz) measured from baseline MEG
Enhed: transcranial alternating current stimulation (tACS)
active control tACS will stimulate the brain at 40Hz

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
magnitude of alpha frequency band power
Tidsramme: Periprocedural
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.
Periprocedural

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
standard deviation in R-R length
Tidsramme: Periprocedural
standard deviation in R-R length (SDNN), a measure of heart rate variability from RR interval tachogram derived from EKG.
Periprocedural
number of spontaneous skin conductance fluctuations
Tidsramme: Periprocedural
number of spontaneous skin conductance fluctuations will be measured from galvanic skin conductance response time-series data.
Periprocedural

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Cleveland Clinic

Samarbejdspartnere

National Center for Complementary and Integrative Health (NCCIH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

18. august 2026

Først indsendt, der opfyldte QC-kriterier

26. august 2026

Først opslået (Faktiske)

28. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 26-220
  • R21AT013595 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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