Meditation Effects on Brain Function in Rheumatoid Arthritis

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT03975595

Collaborator

National Institutes of Health (NIH) (NIH), University of Maryland, Baltimore (Other), University of California, San Diego (Other), University of Utah (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)

Enrollment

Location

Arms

24.8

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. The investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20) or Intervention B (n=20). At post-intervention, participants will undergo functional MRI (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Behavioral: Meditation Intervention A Behavioral: Meditation Intervention B	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Meditation Effects on Brain Function in Rheumatoid Arthritis

Actual Study Start Date :

Oct 7, 2019

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Meditation Group A A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).	Behavioral: Meditation Intervention A This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
Active Comparator: Meditation Group B A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).	Behavioral: Meditation Intervention B This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.

Arm

Intervention/Treatment

Active Comparator: Meditation Group A

A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).

Behavioral: Meditation Intervention A

This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.

Active Comparator: Meditation Group B

A brief meditation intervention involving guided breathing and/or attention exercises (further information withheld to preserve blinding).

Behavioral: Meditation Intervention B

This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.

Outcome Measures

Primary Outcome Measures

Lateral Orbital Frontal Cortex Activation [Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.]
Activation in the Lateral Orbital Frontal Cortex will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention A in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.
Nucleus Accumbens Activation [Measured at the post-Intervention time point during an MRI scan,approximately 60 minutes.]
Activation in the Nucleus Accumbens will be quantitatively measured as the difference in cerebral blood flow (CBF) response during noxious thermal stimulation while participants actively practice Intervention B in the scanner, compared to the CBF response during noxious thermal stimulation while participants rest. The unit of measure will be milliliter per 100 gram brain tissue per minute.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Withheld to preserve recruitment integrity.

Exclusion Criteria:

Withheld to preserve recruitment integrity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Johns Hopkins University
National Institutes of Health (NIH)
University of Maryland, Baltimore
University of California, San Diego
University of Utah
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Principal Investigator: Patrick Finan, Ph.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT03975595

Other Study ID Numbers:

IRB00192687
R61AT010134

First Posted:

Jun 5, 2019

Last Update Posted:

Jun 3, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Jun 3, 2022