Brain Mechanisms Supporting Meditation-based Analgesia

June 7, 2019 updated by: Fadel Zeidan, University of California, San Diego

Identifying the Neurofunctional Connections Supporting Mindfulness Meditation Based Analgesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mindfulness Meditation Group
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
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.
Other Names:
  • mental training
ACTIVE_COMPARATOR: Book Listening Control
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
Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.
Other Names:
  • mental training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood oxygenation level dependent (BOLD) signaling
Time Frame: 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.
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
Time Frame: 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.
Up to 3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale (PCS)
Time Frame: up to 3 weeks
The PCS is a 13 item scale, with each item rated on a 5-point scale between: 0 (Not at all) and 4 (all the time). The PCS is broken into three subscales including: magnification, rumination, and helplessness. The total range of scores is between 0-52 with higher values reflecting more salient impacts of pain on one's day to day experience.
up to 3 weeks
Respiration Rate
Time Frame: Up to 3 weeks
A respiratory transducer (TSD 201; Biopac Systems) will be placed around the chest to measure the paticipant's rate of respiration.
Up to 3 weeks
Heart Rate
Time Frame: up to 3 weeks
Pulse oximeter (OXY-MRI-SPO2; Biopac Systems) will be placed on the left index finger to measure the paticipant's heart rate.
up to 3 weeks
State Anxiety Inventory (SAI)
Time Frame: up to 3 weeks
This inventory is a 20 question test used to measure a subject's state of anxiety. A numeric value between 1 (Not at all) and 4 (Very Much So) is provided in response to each statement. The range of scores for this test is between 20 and 80, with higher scores reflecting higher estimates of anxiety.
up to 3 weeks
Freiburg Mindfulness Inventory (FMI)
Time Frame: up to 3 weeks
The FMI is a 14 item measure of mindfulness. Each declarative statement is measured on a 4 point scale ranging from: 1 (Rarely) to 4 (Almost Always). A couple of the items are reverse scored. Higher scores reflect higher states of mindfulness.
up to 3 weeks
Beck's Depression Inventory (BDI)
Time Frame: up to 3 weeks

This a 21-item multiple choice self-report inventory used to measure the severity of depression. A score between 0 and 3 is applied to each question. Higher total scores indicate more severe depressive symptoms.

0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression
up to 3 weeks
Multidimensional Iowa Suggestibility Scale (MISS) short form
Time Frame: up to 3 weeks
The MISS includes five suggestibility subscales (consumer, physiological, physiological reactivity, persuadability, and peer conformity) and two companion scales (unpersuadability and the short suggestibility scale). The five suggestibility subscales can be summed to give the suggestibility total score. Higher values equate to higher levels of suggestibility.
up to 3 weeks
Positive and Negative Affective Scale (PANAS)
Time Frame: up to 3 weeks
PANAS is composed of two mood scales, one that measures positive affect and the other which measures negative affect. It uses a 20 item test that employs a 5-point rating scale ranging from very slightly or not at all (1) to extremely so (5). Positive affect scores and negative affect scores are calculated separately by adding each group independently. For the positive items, higher scores represent higher levels of positive affect. For the negative items, lower scores represent lower levels of negative affect.
up to 3 weeks
Attitude Toward Treatment Inventory (ATTI)
Time Frame: up to 3 weeks
The ATTI is used to monitor a participant's impressions and attitudes about the interventions used in this study (i.e. mindfulness meditation). It supplies 5 multiple-choice questions answered on a 10 point scale, ranging from 0 (not logical) to 9 (very logical). Higher scores reflect more positive subject impressions about the therapeutic interventions.
up to 3 weeks
Profile of Mood States (PoMS) Questionnaire
Time Frame: up to 3 weeks
The PoMS is a psychological rating scale used to assess transient and distinct mood states. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A five-point scale ranging from "not at all" (0) to "extremely" (4) is provided for participants to rate their mood to 65 descriptive adjectives. A total mood disturbance (TMD) score is computed from adding all subscales. High scores reflect high mood disturbance.
up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2018

Primary Completion (ACTUAL)

August 2, 2018

Study Completion (ACTUAL)

August 2, 2018

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (ACTUAL)

January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00040373
  • 4R00AT008238-03 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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