A Brain Imaging Study of Tai Chi on Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia

• Registration Number: NCT01857219
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be invited to complete the second, identical fMRI session about 3 months following completion of the first session. Fibromyalgia subjects will complete their scans before and after a 12-week Tai Chi intervention in collaboration with Tufts Medical Center.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-06
• Study Start: 2013-01
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-20
• Primary Completion: 2015-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Volunteers 18-50 years of age.
• Fibromyalgia for at least the past 3 months, as determined by the referring physician.
• At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria

• Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
• History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
• Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Criteria for healthy adults.

Inclusion Criteria:

• Volunteers 18-50 years of age.
• At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

• Chronic and acute pain (ex. Fibromyalgia).
• History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
• Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Arterial spin labeling (ASL) before and after Tai Chi intervention.	12 weeks	A method to assess cerebral blood flow change (at rest) through functional magnetic in resonance imaging in response to Tai Chi intervention.

Secondary Outcome Measures

Name	Time	Method
Resting-state BOLD fMRI before and after Tai Chi intervention.	12 weeks	A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging in response to Tai Chi intervention.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States