Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT03914105
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2019-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Neuromodulation of Pain Through Music in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-11', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Visual Analogue scale (VAS)', 'timeFrame': '20 minutes', 'description': 'Visual Analogue Scale (VAS) measured at 2 minutes of stimulation during the temporal summation phase, starting from a basic VAS calibrated at 50/100.\n\nPain is assessed continuously throughout this test using a computerized analog visual scale.'}], 'secondaryOutcomes': [{'measure': 'Average VAS of the subject over the period P1', 'timeFrame': '2 minutes', 'description': 'The period P1 represents the first stimulation or the first time summation test. It is a tonic pain test by applying the thermode. The average VAS will be measured during this period.\n\nPain is assessed continuously throughout this test using a computerized analog visual scale.'}, {'measure': 'Average VAS of the subject over the period P2', 'timeFrame': '2 minutes', 'description': 'The period P2 represents the second stimulation or activation of the DNIC (Diffuse Nociceptive Inhibitive Control). This is the induction of cold thermal nociceptive stimulation (CPT : cold pressor test). The average VAS will be measured during this period.\n\nPain is assessed continuously throughout this test using a computerized analog visual scale.'}, {'measure': 'Average VAS of the subject over the period P3', 'timeFrame': '2 minutes', 'description': 'The period P3 represents the third stimulation or the second time summation test. This is the second tonic pain test by applying the thermode.The average VAS will be measured during this period.\n\nPain is assessed continuously throughout this test using a computerized analog visual scale.'}, {'measure': 'Evaluation of numerical scale', 'timeFrame': '20 minutes', 'description': 'Numerical scale (overall numerical scale over the period) will be measured for each stimulation period (P1, P2, P3).\n\nThis scale assesses pain and is graded from 0 (no pain) to 100 (maximum pain imaginable).'}, {'measure': 'Difference in average VAS P1-P3', 'timeFrame': '20 minutes', 'description': 'The difference in average VAS between period P1 and period P3 will be calculated.\n\nPain is assessed continuously throughout this test using a computerized analog visual scale.'}, {'measure': 'Difference in Pressure Pain Threshold (PPT) before and after the procedure', 'timeFrame': '1 hour and 30 minutes', 'description': 'The difference in Pressure Pain Threshold (PPT) will be measured before and after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.', 'detailedDescription': 'Pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two European adults. To meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. Music therapy is a non-medical intervention that is particularly suited to pain problems. The therapeutic use of music is an economical, practical and safe method. Many clinical studies show that this activity promotes a significant decrease in pain. The ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. One hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. A measurement of pain control mechanisms would account for the impact of music on central awareness.\n\nThe purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged 18 to 65\n* Subjects informed of the constraints of the study and having given their written consent.\n* Subjects benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Subjects under 18 and over 65\n* Subjects who have previously participated in a pain study involving the induced pain test.\n* Subjects with serious psychiatric disorders.\n* Subjects with a diagnosis of acute or chronic pain.\n* Subjects who have been taking antalgic substances for less than a week.\n* Subjects with progressive disease not stabilized by medical treatment.\n* Women in menstruation.\n* Pregnant women.\n* Subjects with a score greater than 10 for the Depressive Dimension on Hospital Anxiety and Depression Scale (HADS)\n* Subjects with an anxiety score "state" higher than anxiety "traits" on the Spielberger condition state / traits anxiety inventory (STAI)\n* Subjects with a score of 32 or higher on the Catastrophe Rating Scale (PCS-CF)\n* Non-cooperating person.\n* Person under legal protection\n* Subjects not benefiting from a social security scheme\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT03914105', 'acronym': 'DOUMU1', 'briefTitle': 'Central Neuromodulation of Pain Through Music in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)', 'orgStudyIdInfo': {'id': 'DOUMU1 (29BRC19.0039)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Without music', 'description': 'Test without music', 'interventionNames': ['Procedure: Without music']}, {'type': 'EXPERIMENTAL', 'label': 'With music', 'interventionNames': ['Procedure: With music']}], 'interventions': [{'name': 'Without music', 'type': 'PROCEDURE', 'description': 'The starting condition will be "without music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be no music for the duration.', 'armGroupLabels': ['Without music']}, {'name': 'With music', 'type': 'PROCEDURE', 'description': 'The starting condition will be "with music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be music for the duration.', 'armGroupLabels': ['With music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': "Gildas L'Heveder, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brest University Hospital in France'}, {'name': 'Céline Bodere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brest University Hospital in France'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}