Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT04259203
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the intensity of pain perception', 'timeFrame': 'At baseline and 2 months after', 'description': 'Measure of the intensity of pain perception by VAS at the baseline visit and at the post-treatment visit (2 months later). The difference between both values will allow to calculate a variation index.'}], 'secondaryOutcomes': [{'measure': 'Change of the score at the Brief Pain Inventory', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the Brief Pain Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': 'Change of the score at the McGill Pain Questionnaire', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the McGill Pain Questionnaire at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': 'Change of the score at the Beck Depression Inventory', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the Beck Depression Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': 'Change of the score at the Fatigue Severity Scale', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the Fatigue Severity Scale at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': "Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)", 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the PDQ-8 at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': "Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)", 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the SCOPA-PS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': 'Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the EQ-5D-5L at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}, {'measure': 'Change in the dose of analgesic treatments', 'timeFrame': 'At baseline and 2 months after', 'description': 'Analgesic treatments will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index.'}, {'measure': 'Change in the dose of psychotropic medications', 'timeFrame': 'At baseline and 2 months after', 'description': 'Psychotropic medications will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index.'}, {'measure': 'Change of the score at MDS-UPDRS', 'timeFrame': 'At baseline and 2 months after', 'description': 'Completion of the MDS-UPDRS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['No-motor symptoms', 'Pain perception', 'Quality of life', 'Hypnosis', 'Auto-hypnosis'], 'conditions': ['Parkinson Disease', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': "This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.", 'detailedDescription': "A large proportion of patients with Parkinson's disease suffer of chronic pain directly related to the disease. The management of painful symptoms is difficult and currently, there is no commonly admitted guidelines.\n\nSeveral studies have shown the efficacy of Erickson hypnosis to reduce the perception of chronic pain in different conditions. This efficacy has never been tested in Parkinson's disease.\n\nThe objective of this study is to assess the efficacy of Erickson hypnosis protocol, compared to usual care, for the management of Parkinson's disease-related chronic pain.\n\nThe study team assume that Erickson hypnosis will be more efficient than usual care to reduce perceived chronic pain. They also assume that regular practice of autohypnosis will contribute to long-term efficacy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women\n* 18 to 80 years old\n* idiopathic Parkinson's disease\n* without neurological co-morbidity\n* Suffering from chronic pain (for at least 3 months), related to Parkinson's disease\n* Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain\n* antiparkinsonian, analgesic and psychotropic treatments stable for 1-month\n* having a health insurance\n* signed informed consent form\n\nExclusion Criteria:\n\n* Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome\n* Early untreated patient\n* Patient with acute intercurrent pain\n* Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.)\n* Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) \\<24\n* Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2\\> 1)\n* Patient with a apathy (MDS-UPDRS 1.5\\> 1)\n* Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2\\> 1)\n* Patient under the protection of adults\n* Pregnant or lactating woman"}, 'identificationModule': {'nctId': 'NCT04259203', 'acronym': 'DOLHYP-PARK-1', 'briefTitle': "Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease", 'orgStudyIdInfo': {'id': '2018-51'}, 'secondaryIdInfos': [{'id': '2019-A00539-48', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erickson hypnosis', 'description': '5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.', 'interventionNames': ['Behavioral: Erickson hypnosis']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual management of pain symptoms'}], 'interventions': [{'name': 'Erickson hypnosis', 'type': 'BEHAVIORAL', 'description': 'Erickson hypnosis sessions performed by an experienced hypnotherapist, according to a pre-established protocol : 5 sessions (1 per week). Between each session : exercise of auto-hypnosis by the patient himself, at home', 'armGroupLabels': ['Erickson hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Chu Cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59800', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Hopital Charles Nicolle Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Purpan Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Luc Defebvre, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'France Parkinson Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}