Real-Time fMRI Feedback Effects on Pain Perception
18 de marzo de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Experimental: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Average Unpleasantness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jeffery J Borckardt, PhD, Medical University of South Carolina
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de noviembre de 2010
Finalización primaria (Actual)
1 de diciembre de 2016
Finalización del estudio (Actual)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
10 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2012
Publicado por primera vez (Estimar)
30 de abril de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
18 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HR # 20270
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .