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Clinical Trials/NCT02908022
NCT02908022
Completed
Not Applicable

Optimization of Brain-based Mechanisms Supporting Psychosocial Aspects of Acupuncture Therapy - a Hyperscanning fMRI Study

Massachusetts General Hospital2 sites in 1 country180 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physician-patient Relationship
Sponsor
Massachusetts General Hospital
Enrollment
180
Locations
2
Primary Endpoint
Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.

Detailed Description

First phase: At the training sessions, both clinician and patient will fill out a set of questionnaires and go through standardized psychophysical tests for assessing visual displays of affect. They will also be informed of the efficacy of the electroacupuncture in relieving pain during the experiment. During the clinical examination, the clinician will follow clinical exam protocol and do an intake of the fibromyalgia (FM) patient, including a physical exam and pain assessment. While in the scanner, the clinician will receive painful stimulations with a pressure cuff on the leg over an 8-minute paradigm in order to get cerebral representation. The patient will then be placed in a different scanner running simultaneously and will experience painful stimulations with a pressure cuff while interacting via live camera with the clinician in the other scanner. When visually prompted via cues on a screen, the clinician will activate analgesia for the patient, through a response device (response box) in clinician's one hand. After each trial of pain with/without treatment, the clinicians will be asked "how did you feel about the outcome (extremely positive - extremely negative)", and how satisfied are you (Not at all satisfied - Very satisfied) on Numerical Rating Scales (NRS). The patient will also give ratings after each trial of pain with/without treatment. They will be asked "how did you feel about the outcome (extremely positive - extremely negative)?", and "how painful was the cuff (Not painful - Extremely painful)?" on NRS. After the scan, both clinician and patient will be asked to rate anxiety during the presence of visual stimulus preceding cuff activation (not at all anxious - extremely anxious). After the final MRI session, the clinician and the patient will both be given the chance to report their responses to the treatment and then debriefed. Second phase: At training session both clinician and patient will fill out a set of questionnaires. During the first MRI session the clinician will receive painful stimulations with a pressure cuff on the leg over a 6-minute paradigm in order to get cerebral representation. The patient will then be placed in a different scanner running simultaneously and will experience pain stimulation with the pressure cuff while interacting via live camera with the clinician in the other scanner. When visually prompted via cues on a screen, the clinician will activate analgesia for the patient, through a response device (response box) in clinician's hand. Both patient and acupuncturist will be asked to give ratings of pain and other parameters during the scan. Following the first MRI session, the patient will attend biweekly acupuncture treatment sessions with the clinician (6 treatments total). During the first session the clinician will be introduced to the patient and do a general intake in addition to the acupuncture treatment. The final MRI session will be identical to the first.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
May 1, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vitaly Napadow, Ph.D., Lic.Ac.

Associate Professor, Harvard Medical School; Director, Center for Integrative Pain NeuroImaging (CiPNI)

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy

Time Frame: Up to 60 months

Patient/clinician concordance in brain activation will be assessed by functional Magnetic Resonance Imaging, simultaneously for both the patient and the clinician

Secondary Outcomes

  • Correlation between patient/clinician brain activity concordance and pain relief from electroacupuncture therapy(Up to 60 months)

Study Sites (2)

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