Meditation Effects on Brain Function in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Meditation Effects on Brain Function in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975595
• Other study ID #: IRB00192687
• Secondary ID: R61AT010134
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: February 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Withheld to preserve recruitment integrity.

Exclusion Criteria:

• Withheld to preserve recruitment integrity.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateral Orbital Frontal Cortex Activation	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.	Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.
Primary	Nucleus Accumbens Activation	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 (ml/100g/min). There is no normal range for this measure.	Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes