Brain Mechanisms Supporting Meditation-based Analgesia

Not Applicable

Completed

• Conditions: Pain

• Registration Number: NCT03414138
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Study Start: 2018-04-20
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood oxygenation level dependent (BOLD) signaling	Up to 3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale Pain Ratings as a function of mindfulness-based mental training	Up to 3 weeks	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States