Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Brain Imaging-fMRI
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.
Detailed Description
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.
Investigators
Vitaly Napadow, LICAC, PhD
Professor
Spaulding Rehabilitation Hospital
Eligibility Criteria
Inclusion Criteria
- •Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria
- •Are on stable doses of medication for 30 days prior to entering the study and agree not to change medications or dosages during the trial
- •Ability to fully understand and consent to study procedures
- •Baseline pain intensity of at least 4/10
- •Pain duration of at least 6 months
Exclusion Criteria
- •Any longer period of work experience involving pain treatment, pain rehabilitation etc.
- •Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
- •Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
- •History of significant head injury
- •Inability to respond accurately to the pain-relieving intervention in the behavioral part of the experiment, indicating a lack of response to the expectancy manipulation. If the healthy volunteer or clinician is not a responder to the behavioral expectancy induction he or she will be excluded.
- •Unwillingness to receive brief experimental pain.
- •Leg pain or health issues that may interfere with the study procedures.
- •Comorbid acute pain condition
- •Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- •Current use of opioid analgesics
Outcomes
Primary Outcomes
Brain Imaging-fMRI
Time Frame: Up to 6 months
Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.
Secondary Outcomes
- Brain Imaging-EEG(Up to 6 months)