Brain Mechanisms Supporting Meditation-based Analgesia

Study Overview
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Brief Summary
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Mindfulness meditation has been shown to reduce pain in experimental and clinical settings, and the neural mechanisms underlying this analgesia are distinct from that of placebo related beliefs in the utility of the meditation. Although previous studies have identified potential cortical and sub-cortical targets responsible for mediating these effects, the connectional relationships between them remains largely unexplored. The present study will use blood-oxygen-level dependent (BOLD) neuroimaging to assess functional connections supporting mindfulness meditation.

Detailed Description
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Mindfulness meditation, significantly reduces pain in experimental and clinical settings. Although findings from this laboratory provide novel insights into some of the brain mechanisms supporting the modulation of pain by meditation , the specific analgesic mechanisms engaged during mindfulness meditation remain poorly characterized. To date, there are no studies that have identified the neurofunctional connections supporting mindfulness meditation-based pain relief. Employing fMRI, the objective of this study will be to determine the neural systems of action supporting mindfulness-based pain relief. The study will determine if higher order brain regions are involved in mindfulness-based analgesia. The results from this aim will identify a neural marker(s) for meditation-related pain relief, a critical step in defining how meditation reduces pain.

Official Title
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Identifying the Neurofunctional Connections Supporting Mindfulness Meditation Based Analgesia

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Mindfulness Training
* Behavioral: Book Listening Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal volunteers between ages 18 and 65. Men and women of all races will be included Exclusion Criteria: Subjects with a history of psychiatric or neurological disorders. Subjects will be excluded if they report being claustrophobic. Subjects with a prior history of meditation training will be excluded. Subjects with ferrous metal or electronic devices (e g., pacemakers) implanted in there body will be excluded. Pregnant subjects will be excluded. Subjects that demonstrate no pain to noxious temperatures (>49°C) or excessive responses to temperatures at or below 43°C will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Healthy research participants, trained to psychophysically rate their experience in response to a range of thermal stimuli, will be randomly assigned to one of two experimental groups (mindfulness meditation n=20 or deep-breathing meditation n=20). After receiving four twenty-minute meditation training sessions, participants will return for a final session of thermal testing while lying in the MRI scanner. Participants will be exposed to 4 blocks of testing, using thermal stimuli cycled between painful (49°C) and non-painful (35°C) temperatures for 6 minutes. Blood oxygen-level dependent imaging will be used to map the functional connectivity of brain regions in response to the thermal fluctuations. In the first two blocks participants will lie quietly with eyes closed. After a 10 minute rest, subjects will begin meditating and the thermal testing will resume.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation Group<br>Research volunteers will participate in four sessions (20 min/session) of mindfulness training. Participants are taught that perceived sensory events are momentary and fleeting, requiring no further evaluation. They will be asked to close their eyes, relax and focus on the flow of their breathing by simply letting go of discursive thoughts. | Behavioral: Mindfulness Training<br>* A well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] will be used to teach patients to independently practice mindfulness meditation.<br>* Other names: mental training;|
| Active Comparator: Book Listening Control<br>Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 4 session sequence is meant to match features of the experimental meditation sessions, including attention to the recording, room setting, social support, conditioning, and time elapsed during the sessions. We do not expect that this group will demonstrate significant blood oxygenation changes as a function of the intervention. | Behavioral: Book Listening Control<br>* Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.<br>* Other names: mental training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygenation level dependent (BOLD) signaling | Changes in blood oxygenation levels to thermally noxious stimuli (49°C) will be assessed, and planned comparisons will be performed between subjects trained in mindfulness meditation and those trained in deep-breathing meditation. | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training | The visual analog scale (VAS) measures pain ratings that will be assessed in response to noxious (49°C) thermal stimuli applied to the back of the right calf muscle. Pain intensity and pain unpleasantness ratings will be assessed with a Visual Analog Scale. The minimum rating (0) is designated as no pain whereas the maximum (10) is labeled as most intense imaginable or most unpleasant imaginable. Higher values corresponded to higher perceived pain ratings. Baseline pain ratings will be assessed on session one and again at session six. | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Mindfulness, Meditation, fMRI