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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03975595
Other study ID # IRB00192687
Secondary ID R61AT010134
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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