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Meditation Effects on Brain Function in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03975595
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Maryland, College Park
University of California, San Diego
University of Utah
Information provided by (Responsible Party):
Johns Hopkins University

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), Intervention B (n=20), or Intervention C (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 Behavioral: Meditation Intervention C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  1. Lateral Orbital Frontal Cortex Activation [ Time Frame: 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.

  2. Nucleus Accumbens Activation [ Time Frame: 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.



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Withheld to preserve recruitment integrity.

Exclusion Criteria:

  • Withheld to preserve recruitment integrity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975595


Contacts
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Contact: Patrick Finan, Ph.D. 410-550-7901 pfinan1@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
University of Maryland, College Park
University of California, San Diego
University of Utah
Investigators
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Principal Investigator: Patrick Finan, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03975595     History of Changes
Other Study ID Numbers: IRB00192687
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases