Brain Mechanisms Supporting Meditation-based Analgesia

Pain Clinical Trial

Official title:

Identifying the Neurofunctional Connections Supporting Mindfulness Meditation Based Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414138
• Other study ID #: IRB00040373
• Secondary ID: 4R00AT008238-03
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: August 2, 2018

Study information

• Verified date: June 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.
• Book Listening Control
Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 64 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiration Rate	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
Other	Heart Rate	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
Other	State Anxiety Inventory (SAI)	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
Other	Freiburg Mindfulness Inventory (FMI)	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
Other	Beck's Depression Inventory (BDI)	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
Other	Multidimensional Iowa Suggestibility Scale (MISS) short form	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
Other	Positive and Negative Affective Scale (PANAS)	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
Other	Attitude Toward Treatment Inventory (ATTI)	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
Other	Pain Catastrophizing Scale (PCS)	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
Other	Profile of Mood States (PoMS) Questionnaire	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
Primary	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	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