Real-Time fMRI Feedback Effects on Pain Perception
18. mars 2019 oppdatert av: Medical University of South Carolina
The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein thermal pain stimuli will be used to elicit activation of the pain neuro-matrix.
All participants will undergo thermal pain threshold testing before and after fMRI scan.
Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied before fMRI and after fMRI.
All participants will be given prompts to apply a set of cognitive pain-control strategies.
Half of the participants will receive real-time fMRI feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC).
It is hypothesized that those receiving real-time feedback of brain activity thought to be involved with analgesic effects will demonstrate greater analgesia associated with the application of the cognitive control techniques after fMRI paradigm (decreased pain intensity and unpleasantness ratings and increased thermal pain thresholds) than those who are not given feedback before fMRI paradigm.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults ages 18-65
Exclusion Criteria:
- Clinical depression
- Anxiety
- Substance dependence or chronic pain
- Ferrous metal implants
- Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: ACC Real Time fMRI Feedback
Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel). Participants will be instructed to "focus on the thermal stimuli" for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy. The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the rACC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display. |
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body).
Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain.
Attempt to perceive the stimulus as low intensity rather than high intensity.
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to take control of their perception of the painful experience.
|
|
Eksperimentell: PFC Real Time fMRI Feedback
Each participant will undergo thermal pain threshold assessments ten times using the Medoc Pathway System with MRI-compatible ATS Thermode (30mmX30mm; Medoc Inc, Israel).
Participants will be instructed to "focus on the thermal stimuli" for the first 5 trials, and to engage in three cognitive pain inhibition strategies (Attention/Distraction Strategy, Stimulus Quality/Severity Strategy, and the Control Strategy.
The participants will be randomly assigned to receive Real Time fMRI Feedback of inverse activation in the PFC after each pain/rest block during the last 3 fMRI scans in the form of two simple thermometer images on the in-scanner computer display.
|
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body).
Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain.
Attempt to perceive the stimulus as low intensity rather than high intensity.
One of three Cognitive Pain Inhibition Strategies.
The Participant will be instructed to attempt to take control of their perception of the painful experience.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Average Unpleasantness
Tidsramme: Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI. Participants will be asked to rate pain unpleasantness, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI). 0="no unpleasantness" and 10="worst unpleasantness imaginable" |
Before and After fMRI Paradigm, an average of 2 hours
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Average Pain Rating
Tidsramme: Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI scan.Participants will be asked to rate painfulness of the thermal stimuli applied, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI).
0="no pain" and 10="worst pain imaginable"
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Before and After fMRI Paradigm, an average of 2 hours
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Ability to Distract
Tidsramme: Before and After fMRI Paradigm, an average of 2 hours
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All participants will undergo thermal pain threshold testing before and after fMRI paradigm.
Participants will rate the ability to distract themselves from the thermal stimuli, on a scale of 0-10, before fMRI paradigm (Baseline) and after fMRI paradigm, 0="not able to distract at all" and 10="completely able to distract".
A Higher rating represents greater ability to distract from thermal pain stimuli.
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Before and After fMRI Paradigm, an average of 2 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jeffery J Borckardt, PhD, Medical University of South Carolina
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2010
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
10. februar 2012
Først innsendt som oppfylte QC-kriteriene
26. april 2012
Først lagt ut (Anslag)
30. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .