Clinical trial NCT03414138: Brain Mechanisms Supporting Meditation-based Analgesia
Official title: Identifying the Neurofunctional Connections Supporting Mindfulness Meditation Based Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Mindfulness
Meditation
fMRI
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) signaling
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training
timeFrame: Up to 3 weeks
Other outcomes:
measure: Respiration Rate
timeFrame: Up to 3 weeks
measure: Heart Rate
timeFrame: up to 3 weeks
measure: State Anxiety Inventory (SAI)
timeFrame: up to 3 weeks
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: up to 3 weeks
measure: Beck's Depression Inventory (BDI)
timeFrame: up to 3 weeks
measure: Multidimensional Iowa Suggestibility Scale (MISS) short form
timeFrame: up to 3 weeks
measure: Positive and Negative Affective Scale (PANAS)
timeFrame: up to 3 weeks
measure: Attitude Toward Treatment Inventory (ATTI)
timeFrame: up to 3 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: up to 3 weeks
measure: Profile of Mood States (PoMS) Questionnaire
timeFrame: up to 3 weeks
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Fadel Zeidan, PhD
role: PRINCIPAL_INVESTIGATOR
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