Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT06157866
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2023-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Training to Enhance Brain Concordance During Acupuncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D012736', 'term': 'Sex Education'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D044347', 'term': 'Sexology'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brief Pain Inventory (BPI) - Pain Interference', 'timeFrame': 'Up to 6 months', 'description': 'Brief Pain Inventory (BPI) is a validated 16 item questionnaire designed to assess the severity and interference of pain experienced. Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).'}], 'primaryOutcomes': [{'measure': 'Brain Imaging-fMRI', 'timeFrame': 'Up to 6 months', 'description': 'Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.'}], 'secondaryOutcomes': [{'measure': 'Brain Imaging-EEG', 'timeFrame': 'Up to 6 months', 'description': 'Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyperscan fmri', 'hyperscan EEG', 'acupuncture', 'fibromyalgia', 'chronic pain'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria\n* 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\n* Ability to fully understand and consent to study procedures\n* Baseline pain intensity of at least 4/10\n* Pain duration of at least 6 months\n\nExclusion Criteria:\n\n* Any longer period of work experience involving pain treatment, pain rehabilitation etc.\n* Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual\n* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.\n* History of significant head injury\n* 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.\n* Unwillingness to receive brief experimental pain.\n* Leg pain or health issues that may interfere with the study procedures.\n* Comorbid acute pain condition\n* Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia\n* Current use of opioid analgesics\n* Concurrent inflammatory or autoimmune disease\n* Documented peripheral neuropathy\n* Pregnant\n* Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)\n* History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)\n* Psychiatric hospitalization in the past 6 months\n* Unwillingness to withhold from consuming marijuana 12 hours prior to scans\n* Unwillingness to withhold from consuming nicotine 4 hours prior to scans\n* Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol.\n* Is an actual clinical patient of the clinician subject\n* Recent history of formal meditation-based training'}, 'identificationModule': {'nctId': 'NCT06157866', 'briefTitle': 'Cognitive Training to Enhance Brain Concordance During Acupuncture', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture', 'orgStudyIdInfo': {'id': '2023P003155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Training', 'description': 'Participants will meet with a pain specialist who will conduct a specific form of cognitive training targeting fibromyalgia.', 'interventionNames': ['Other: Electroacupuncture', 'Behavioral: Cognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education Training', 'description': 'Participants will meet with a pain specialist to receive education training related to fibromyalgia.', 'interventionNames': ['Other: Electroacupuncture', 'Behavioral: Education Training']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'OTHER', 'description': "During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist.", 'armGroupLabels': ['Cognitive Training', 'Education Training']}, {'name': 'Cognitive Training', 'type': 'BEHAVIORAL', 'description': 'Cognitive training with a pain specialist.', 'armGroupLabels': ['Cognitive Training']}, {'name': 'Education Training', 'type': 'BEHAVIORAL', 'description': 'Education training with a pain specialist.', 'armGroupLabels': ['Education Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seneca Ellis', 'role': 'CONTACT', 'email': 'sellis11@mgb.org', 'phone': '617-952-6484'}, {'name': 'Lara Gardiner', 'role': 'CONTACT', 'email': 'lgardiner1@mgb.org', 'phone': '617-952-6483'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}, {'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seneca Ellis', 'role': 'CONTACT', 'email': 'sellis11@mgb.org', 'phone': '617-952-6484'}, {'name': 'Lara Gardiner', 'role': 'CONTACT', 'email': 'lgardiner1@mgb.org', 'phone': '617-952-6483'}, {'name': 'Vitaly Napadow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}, {'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seneca Ellis', 'role': 'CONTACT', 'email': 'sellis11@mgb.org', 'phone': '617-952-6484'}, {'name': 'Lara Gardiner', 'role': 'CONTACT', 'email': 'lgardiner1@mgb.org', 'phone': '617-952-6483'}, {'name': 'Robert Edwards, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'centralContacts': [{'name': 'Seneca Ellis', 'role': 'CONTACT', 'email': 'sellis11@mgb.org', 'phone': '617-952-6484'}, {'name': 'Arvina Grahl, PhD', 'role': 'CONTACT', 'email': 'agrahl@mgh.harvard.edu'}], 'overallOfficials': [{'name': 'Vitaly Napadow, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Per NIH guidelines'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vitaly Napadow, LICAC, PhD', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}