Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02779218
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of a reeducation session as assessed by amplitude of motor evoked potential', 'timeFrame': 'Day 1', 'description': 'At the inclusion visit 25 minutes after stimulation'}, {'measure': 'Effect of a reeducation session as assessed by amplitude of motor evoked potential', 'timeFrame': 'Week 1', 'description': '25 minutes after stimulation'}, {'measure': 'Effect of a reeducation session as assessed by amplitude of motor evoked potential', 'timeFrame': 'Week 2', 'description': '25 minutes after stimulation'}, {'measure': 'Effect of a reeducation session as assessed by amplitude of motor evoked potential', 'timeFrame': 'Week 3', 'description': '25 minutes after stimulation'}], 'secondaryOutcomes': [{'measure': 'Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 1', 'description': 'After the first stimulation'}, {'measure': 'Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 2', 'description': 'After the second stimulation'}, {'measure': 'Resting Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 3', 'description': 'After the third stimulation'}, {'measure': 'Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 1', 'description': 'After the first stimulation'}, {'measure': 'Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 2', 'description': 'After the second stimulation'}, {'measure': 'Active Motor Threshold as assessed by minimal intensity to evoke a motor evoked potential', 'timeFrame': 'Week 3', 'description': 'After the third stimulation'}, {'measure': 'Intensity curve as assessed by variation of intensity of motor evoked potential', 'timeFrame': 'Week 1', 'description': 'After the first stimulation'}, {'measure': 'Intensity curve as assessed by variation of intensity of motor evoked potential', 'timeFrame': 'Week 2', 'description': 'After the second stimulation'}, {'measure': 'Intensity curve as assessed by variation of intensity of motor evoked potential', 'timeFrame': 'Week 3', 'description': 'After the third stimulation'}, {'measure': 'Motricity of upper limb recovering as assessed by Fugl Meyer Score', 'timeFrame': 'Day 1', 'description': 'After inclusion visit'}, {'measure': 'Motricity of upper limb recovering as assessed by Fugl Meyer Score', 'timeFrame': 'Week 3', 'description': 'After the third stimulation'}, {'measure': 'Asymmetry index as assessed by resonance magnetic imaging', 'timeFrame': 'Day 1', 'description': 'At the inclusion visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemiplegia'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32414294', 'type': 'RESULT', 'citation': 'Brihmat N, Tarri M, Gasq D, Marque P, Castel-Lacanal E, Loubinoux I. Cross-Modal Functional Connectivity of the Premotor Cortex Reflects Residual Motor Output After Stroke. Brain Connect. 2020 Jun;10(5):236-249. doi: 10.1089/brain.2020.0750. Epub 2020 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.\n\nMeanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.\n\nThe motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-85 years\n* Patients who have experienced a Stroke of more than one month\n* Deficit out of the upper limb (Fugl Meyer member sup \\<50/66)\n* Presence of ECR muscle MEP\n* Able to carry the motor imagery according to a test by measuring chronometer\n* Patient who signed informed consent\n* Subject affiliated to the social security system\n\nExclusion Criteria:\n\n* history of epilepsy or seizure\n* MEP Lack of ECR\n* Presence of a cons-indication for use of magnetic stimulation or MRI:\n\n * Surgical Clips, metal sutures, staples, stent\n * Osteosynthesis devices on the head or neck\n * Pacemaker\n * Implanted hearing aid\n * Ocular foreign body, shrapnel, bullets\n * Metal Worker\n * Heart Valve, endovascular equipment\n * Ventricular bypass valve\n * Pace-maker or neurostimulator\n* Claustrophobia\n* incapable adult Patient, safeguard justice, guardianship or trusteeship\n* Pregnant women and / or breastfeeding (because lack of data in the literature regarding the absence of foetotoxic effect)'}, 'identificationModule': {'nctId': 'NCT02779218', 'acronym': 'MIPAS', 'briefTitle': 'Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke', 'orgStudyIdInfo': {'id': '12 389 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'The patients will receive in order :\n\n1. Paired Associative Stimulation\n2. Paired Associative Stimulation + Motor Imagery exercises\n3. Placebo Paired Associative Stimulation + Motor Imagery exercises', 'interventionNames': ['Procedure: Paired Associative Stimulation', 'Procedure: Paired Associative Stimulation + Motor Imagery exercises', 'Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'The patients will receive in order :\n\n1. Paired Associative Stimulation + Motor Imagery exercises\n2. Placebo Paired Associative Stimulation + Motor Imagery exercises\n3. Paired Associative Stimulation', 'interventionNames': ['Procedure: Paired Associative Stimulation', 'Procedure: Paired Associative Stimulation + Motor Imagery exercises', 'Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'The patients will receive in order :\n\n1. Placebo Paired Associative Stimulation + Motor Imagery exercises\n2. Paired Associative Stimulation\n3. Paired Associative Stimulation + Motor Imagery exercises', 'interventionNames': ['Procedure: Paired Associative Stimulation', 'Procedure: Paired Associative Stimulation + Motor Imagery exercises', 'Procedure: Placebo Paired Associative Stimulation + Motor Imagery exercises']}], 'interventions': [{'name': 'Paired Associative Stimulation', 'type': 'PROCEDURE', 'description': 'Patient with Paired Associative Stimulation only', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'Paired Associative Stimulation + Motor Imagery exercises', 'type': 'PROCEDURE', 'description': 'Patient with Paired Associative Stimulation + Motor Imagery exercises', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}, {'name': 'Placebo Paired Associative Stimulation + Motor Imagery exercises', 'type': 'PROCEDURE', 'description': 'Patient with placebo Paired Associative Stimulation + Motor Imagery exercises', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Evelyne CASTEL-LACANAL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'physical medecine and readaption'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}