Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 7:44 PM
Study NCT ID:
NCT05748028
Status:
RECRUITING
Last Update Posted:
2025-01-30
First Post:
2023-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D010146', 'term': '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': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2023-01-26', 'studyFirstSubmitQcDate': '2023-02-17', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence and Characterization of Pain', 'timeFrame': 'At the recruitment', 'description': "Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score"}, {'measure': 'Prevalence and Characterization of Pain', 'timeFrame': 'At the end of the rehabilitation program, an average of 30 days', 'description': "Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms through KING'S PAIN score"}], 'secondaryOutcomes': [{'measure': 'Autonomic symptoms', 'timeFrame': 'At the recruitment', 'description': "Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire"}, {'measure': 'Autonomic symptoms', 'timeFrame': 'At the end of the rehabilitation program, an average of 30 days', 'description': "Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms through the score of SCOPA-AUT questionnaire"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'autonomic symptoms', 'rehabilitation'], 'conditions': ['Parkinson Disease', 'Multiple System Atrophy']}, 'referencesModule': {'references': [{'pmid': '23716362', 'type': 'BACKGROUND', 'citation': 'Bakkers M, Faber CG, Hoeijmakers JG, Lauria G, Merkies IS. Small fibers, large impact: quality of life in small-fiber neuropathy. Muscle Nerve. 2014 Mar;49(3):329-36. doi: 10.1002/mus.23910. Epub 2013 Jun 28.'}, {'pmid': '15036166', 'type': 'BACKGROUND', 'citation': "Quittenbaum BH, Grahn B. Quality of life and pain in Parkinson's disease: a controlled cross-sectional study. Parkinsonism Relat Disord. 2004 Mar;10(3):129-36. doi: 10.1016/j.parkreldis.2003.12.001."}, {'pmid': '26309254', 'type': 'BACKGROUND', 'citation': "Valkovic P, Minar M, Singliarova H, Harsany J, Hanakova M, Martinkova J, Benetin J. Pain in Parkinson's Disease: A Cross-Sectional Study of Its Prevalence, Types, and Relationship to Depression and Quality of Life. PLoS One. 2015 Aug 26;10(8):e0136541. doi: 10.1371/journal.pone.0136541. eCollection 2015."}, {'pmid': '18515869', 'type': 'BACKGROUND', 'citation': "Nolano M, Provitera V, Estraneo A, Selim MM, Caporaso G, Stancanelli A, Saltalamacchia AM, Lanzillo B, Santoro L. Sensory deficit in Parkinson's disease: evidence of a cutaneous denervation. Brain. 2008 Jul;131(Pt 7):1903-11. doi: 10.1093/brain/awn102. Epub 2008 May 31."}, {'pmid': '22942216', 'type': 'BACKGROUND', 'citation': 'Asahina M, Vichayanrat E, Low DA, Iodice V, Mathias CJ. Autonomic dysfunction in parkinsonian disorders: assessment and pathophysiology. J Neurol Neurosurg Psychiatry. 2013 Jun;84(6):674-80. doi: 10.1136/jnnp-2012-303135. Epub 2012 Sep 1.'}, {'pmid': '20108376', 'type': 'BACKGROUND', 'citation': "Linder J, Stenlund H, Forsgren L. Incidence of Parkinson's disease and parkinsonism in northern Sweden: a population-based study. Mov Disord. 2010 Feb 15;25(3):341-8. doi: 10.1002/mds.22987."}, {'pmid': '26096067', 'type': 'BACKGROUND', 'citation': "Chaudhuri KR, Rizos A, Trenkwalder C, Rascol O, Pal S, Martino D, Carroll C, Paviour D, Falup-Pecurariu C, Kessel B, Silverdale M, Todorova A, Sauerbier A, Odin P, Antonini A, Martinez-Martin P; EUROPAR and the IPMDS Non Motor PD Study Group. King's Parkinson's disease pain scale, the first scale for pain in PD: An international validation. Mov Disord. 2015 Oct;30(12):1623-31. doi: 10.1002/mds.26270. Epub 2015 Jun 11."}, {'pmid': '30363423', 'type': 'BACKGROUND', 'citation': "Rodriguez-Violante M, Alvarado-Bolanos A, Cervantes-Arriaga A, Martinez-Martin P, Rizos A, Chaudhuri KR. Clinical Determinants of Parkinson's Disease-associated Pain Using the King's Parkinson's Disease Pain Scale. Mov Disord Clin Pract. 2017 Feb 6;4(4):545-551. doi: 10.1002/mdc3.12469. eCollection 2017 Jul-Aug."}, {'pmid': '26474316', 'type': 'BACKGROUND', 'citation': "Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424."}, {'pmid': '18725592', 'type': 'BACKGROUND', 'citation': 'Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the impact of the different types of pain and of the domains involved in the autonomic disorders of inpatients and outpatients diagnosed with Parkinson disease (PD) and multiple system atrophy (MSA) admitted to Istituti Clinici Scientifici Maugeri Centers.\n\nThe main aims are:\n\nEvaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms (MSA) Evaluate the effect of rehabilitation on pain and autonomic symptoms Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms (MSA) Assess the impact of pain and autonomic symptoms on quality of life. Participants will perform neurological examination, rehabilitation program and clinical scales.\n\nResearchers will compare the two groups of patients (PD and MSA) and the effect of the rehabilitation on pain, autonomic symptoms and quality of life.", 'detailedDescription': "2% of the population over 65 is affected by Parkinson's disease (PD) or parkinsonism. This represents a significant burden on the health service in countries where the elderly represent 1/5 of the general population. In recent years there has been increased attention on the presence of non-motor disorders in PD patients. Among these, pain and autonomic symptoms are more frequently present and contribute to the worsening of disability and quality of life of the affected patient.\n\nHow much the presence of pain and autonomic symptoms can affect the rehabilitation outcome and how much the rehabilitation treatment itself can improve the painful or autonomic symptomatology is not known, but rehabilitation has an important role in the management of diseases where there are no real treatments capable of cure or slow down the neurodegenerative process.\n\nIn the Maugeri Clinical Scientific Institutes, patients with Parkinson's disease or parkinsonism are hospitalized or followed as outpatients and a personalized rehabilitation setting is ideal for being able to evaluate the patient in a sufficiently wide time frame to be able to appreciate significant changes in clinical parameters.\n\nThe greater knowledge of the impact of the different types of pain and of the domains involved in the autonomic dysfunction will help the clinician to better manage the patient's disability and will contribute to the definition of specific rehabilitation strategies aimed to improve the patient's quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be enrolled from the population of inpatient and outpatient admitted for rehabilitation to ICS Maugeri SpA institutes.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015).\n* Mini-Mental State Examination score at least 10\n\nExclusion Criteria:\n\n* vascular or pharmacological parkinsonism\n* diabetes mellitus\n* hepatic or renal dysmetabolism,\n* hypothyroidism or hyperthyroidism\n* assumption of potentially neurotoxic drugs"}, 'identificationModule': {'nctId': 'NCT05748028', 'briefTitle': "Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms", 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': "Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms: Identification of Predictive Patterns of Rehabilitation Outcome and Evaluation of the Impact on Quality of Life", 'orgStudyIdInfo': {'id': 'SBLAB1/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parkinson Disease', 'description': "Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes", 'interventionNames': ['Other: Rehabilitation', 'Other: Administration of Clinical scales']}, {'label': 'Multiple System Atrophy', 'description': 'Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes', 'interventionNames': ['Other: Rehabilitation', 'Other: Administration of Clinical scales']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.', 'armGroupLabels': ['Multiple System Atrophy', 'Parkinson Disease']}, {'name': 'Administration of Clinical scales', 'type': 'OTHER', 'description': 'All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.', 'armGroupLabels': ['Multiple System Atrophy', 'Parkinson Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82037', 'city': 'Telese Terme', 'state': 'Benevento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Provitera, MD', 'role': 'CONTACT', 'email': 'vincenzo.provitera@icsmaugeri.it', 'phone': '+390824909257'}], 'facility': 'ICS Maugeri - IRCCS of Telese Terme', 'geoPoint': {'lat': 41.21752, 'lon': 14.52681}}, {'zip': '25065', 'city': 'Lumezzane', 'state': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Diego Ghianda, MD', 'role': 'CONTACT', 'email': 'diego.ghianda@icsmaugeri.it', 'phone': '0308253186'}], 'facility': 'ICS Maugeri - Lumezzane', 'geoPoint': {'lat': 45.64789, 'lon': 10.26487}}, {'zip': '46042', 'city': 'Castel Goffredo', 'state': 'Mantova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuliana Vezzadini, MD', 'role': 'CONTACT', 'email': 'giuliana.vezzadini@icsmaugeri.it', 'phone': '037677471'}], 'facility': 'ICS Maugeri - Castelgoffredo', 'geoPoint': {'lat': 45.29403, 'lon': 10.473}}, {'zip': '98073', 'city': 'Mistretta', 'state': 'Messina', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Volanti, MD', 'role': 'CONTACT', 'email': 'paolo.volanti@icsmaugeri.it', 'phone': '0921389574'}], 'facility': 'ICS Maugeri - Mistretta', 'geoPoint': {'lat': 37.92823, 'lon': 14.3578}}, {'zip': '28010', 'city': 'Veruno', 'state': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgio Maggioni, MD', 'role': 'CONTACT', 'email': 'giorgio.maggioni@icsmaugeri.it', 'phone': '0322884711'}], 'facility': 'ICS Maugeri - Veruno', 'geoPoint': {'lat': 45.68887, 'lon': 8.52863}}, {'zip': '27040', 'city': 'Montescano', 'state': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cira Fundarò, MD', 'role': 'CONTACT', 'email': 'cira.fundaro@icsmaugeri.it', 'phone': '0385247268'}], 'facility': 'ICS Maugeri - Montescano', 'geoPoint': {'lat': 45.03196, 'lon': 9.28366}}, {'zip': '20138', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Beatrice De Maria, Eng', 'role': 'CONTACT', 'email': 'beatrice.demaria@icsmaugeri.it', 'phone': '0250725260'}], 'facility': 'ICS Maugeri - Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marianna Loi, MD', 'role': 'CONTACT', 'email': 'marianna.loi@icsmaugeri.it', 'phone': '+3903825931'}], 'facility': 'ICS Maugeri - Pavia Boezio', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Isabella Springhetti, MD', 'role': 'CONTACT', 'email': 'isabella.springhetti@icsmaugeri.it', 'phone': '+390382592621'}], 'facility': 'ICS Maugeri - Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Maria Nolano, MD, PhD', 'role': 'CONTACT', 'email': 'maria.nolano@icsmaugeri.it', 'phone': '+390824909257'}, {'name': 'Giuseppe Caporaso', 'role': 'CONTACT', 'email': 'giuseppe.caporaso@icsmaugeri.it', 'phone': '+390824909645'}], 'overallOfficials': [{'name': 'Maria Nolano, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isituti Clinici Scientifici Maugeri SpA SB - IRCCS of Telese Terme'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}