Real-Time fMRI Feedback Effects on Pain Perception
2019년 3월 18일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
South Carolina
-
Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average Unpleasantness
기간: Before and After fMRI Paradigm, an average of 2 hours
|
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
|
|
Average Pain Rating
기간: Before and After fMRI Paradigm, an average of 2 hours
|
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"
|
Before and After fMRI Paradigm, an average of 2 hours
|
|
Ability to Distract
기간: Before and After fMRI Paradigm, an average of 2 hours
|
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.
|
Before and After fMRI Paradigm, an average of 2 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jeffery J Borckardt, PhD, Medical University of South Carolina
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2010년 11월 1일
기본 완료 (실제)
2016년 12월 1일
연구 완료 (실제)
2016년 12월 1일
연구 등록 날짜
최초 제출
2012년 2월 10일
QC 기준을 충족하는 최초 제출
2012년 4월 26일
처음 게시됨 (추정)
2012년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 18일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .