Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02471066
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2015-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2015-06-10', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Psychogenic Movement Disorder Rating Scale (PMDRS= Hinson score between baseline and one month after rTMS treatment', 'timeFrame': 'Inclusion and 1 month later'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression-Severity scale (CGI-SEVERITY/CGI-I/CGI-S)', 'timeFrame': 'inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.'}, {'measure': 'Hospital Anxiety and Depression Scale (HAD/HDRS)', 'timeFrame': 'inclusion, inclusion + 1 month, inclusion + 6 months, inclusion + 12 months.'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': 'inclusion, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.'}, {'measure': 'Temperament and Character Inventory (TCI)', 'timeFrame': 'inclusion, inclusion + 12 months.'}, {'measure': 'Pain scale (VAS)', 'timeFrame': ': inclusion, inclusion + 5 days, inclusion + 1 month, inclusion + 2 months, inclusion + 6 months, inclusion + 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Movement Disorders']}, 'referencesModule': {'references': [{'pmid': '21480152', 'type': 'BACKGROUND', 'citation': 'Dafotakis M, Ameli M, Vitinius F, Weber R, Albus C, Fink GR, Nowak DA. [Transcranial magnetic stimulation for psychogenic tremor - a pilot study]. Fortschr Neurol Psychiatr. 2011 Apr;79(4):226-33. doi: 10.1055/s-0029-1246094. Epub 2011 Apr 8. German.'}, {'pmid': '23385844', 'type': 'BACKGROUND', 'citation': 'Garcin B, Roze E, Mesrati F, Cognat E, Fournier E, Vidailhet M, Degos B. Transcranial magnetic stimulation as an efficient treatment for psychogenic movement disorders. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1043-6. doi: 10.1136/jnnp-2012-304062. Epub 2013 Feb 5.'}, {'pmid': '31180620', 'type': 'RESULT', 'citation': 'Taib S, Ory-Magne F, Brefel-Courbon C, Moreau Y, Thalamas C, Arbus C, Simonetta-Moreau M. Repetitive transcranial magnetic stimulation for functional tremor: A randomized, double-blind, controlled study. Mov Disord. 2019 Aug;34(8):1210-1219. doi: 10.1002/mds.27727. Epub 2019 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'The management of functional psychogenic movement disorders (FNPMD) is challenging for neurologists and psychiatrists and only comprehensive multidisciplinary treatment programme can be worthwhile for these patients (Moene et al 2002). Recent functional magnetic resonance imaging studies have demonstrated abnormalities in motor control at cortical level, hyperactivity of limbic system and disturbance of connectivity between these two systems leading to a lack of self-agency, (Voon et al 2010,2011).Two recent studies suggested a possible therapeutic effect of transcranial magnetic stimulation (TMS) in FNPMD (Dakotakis 2011, Garcin, 2013).\n\nIn this protocol our objectives are twofold :\n\n1. to compare the effect of 5 consecutive daily sessions of rTMS on FNPMD in a double-blind randomized controlled study\n2. to study the effect of 3 weekly hypnosis sessions combined with rTMS in FNPMD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Man or woman with FNPMD for at least 2 months,\n* diagnosed from clinical Diagnostic and Statistical Manual V conversive somatoform troubles and Gupta \\& Lang (2009) and Edwards \\& Bahtia 2012 neurological clinical criteria\n\nExclusion criteria:\n\n* Severe progressive psychiatric disorders\n* Cardiac pace-maker\n* Metallic prosthesis\n* Cochlear implants\n* Previous neurosurgery\n* Epilepsy\n* Severe cardiac disease\n* Alcohol or toxic abuse for the last 12 months\n* Drugs such clozapine, bupropion, methadone or theophylline'}, 'identificationModule': {'nctId': 'NCT02471066', 'acronym': 'MOVHYSTIM', 'briefTitle': 'rTMS Effect in Functional Psychogenic Movement Disorders Applied Alone Then Combined With Hypnotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Functional Psychogenic Movement Disorders Followed by a Feasibility Study of a Hypnotherapy Treatment as Adjuvant Therapy.', 'orgStudyIdInfo': {'id': '14 7311 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active rTMS', 'description': '12 patients will be enrolled in this arm.', 'interventionNames': ['Device: rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham rTMS', 'description': '12 patients will be enrolled in this arm.', 'interventionNames': ['Device: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'DEVICE', 'description': '* Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham\n* Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session', 'armGroupLabels': ['active rTMS', 'sham rTMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}