Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-28 @ 3:55 PM
Study NCT ID:
NCT05139732
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003291', 'term': 'Conversion Disorder'}, {'id': 'D010243', 'term': 'Paralysis'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve Cell Metabolism', 'timeFrame': 'day 1', 'description': 'With MRS metabolites are examined specific for cell integrity (N-acetyl-aspartate), cell energy (creatine, lactate), and neurotransmitter (choline, glutamate and glutamine).'}, {'measure': 'Brain Functional Connectivity', 'timeFrame': 'day 1', 'description': 'With fMRI in rest and task condition, the functional connectivity (FC) is examined. With that the functionally integrated relationship between spatially separated brain regions are investigated.'}, {'measure': 'Fiber tracts in three dimensional mapping', 'timeFrame': 'day 1', 'description': 'DWI provides quantitative evaluations by measuring the apparent diffusion coefficient (ADC) and fractional anisotropy (FA), which are scalars of isotropic and anisotropic diffusion. Diffusion tensor imaging (DTI) analyses the three-dimensional shape of the diffusion, also known as diffusion tensor. So, it is used to characterize the magnitude, the degree of anisotropy, and the orientation of directional diffusion of white matter.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with Life Scale questionnaire', 'timeFrame': 'day 1', 'description': 'Likert Scale of 1 (strong disagreement) -7 (strong agreement); 5 Questions in total'}, {'measure': 'Hospital Anxiety and Depression Scale questionnaire', 'timeFrame': 'day 1', 'description': 'Likert Scale of 1 (strong disagreement) -4 (strong agreement); 14 Questions in total'}, {'measure': 'Numerical Rating Scale (NRS) questionnaire', 'timeFrame': 'day 1', 'description': 'Rating the pain on a likert scale of 0 (no pain) -10 (insupportable pain)'}, {'measure': 'Sensibility testing according to International Standards for Neurological Classification of SCI (ISNCSCI)', 'timeFrame': 'day 1', 'description': 'A key point in each of the 28 dermatomes is tested bilaterally using light touch and pin-prick (sharp-dull discrimination). A three-point scale is used for scoring:\n\n0 = absent\n\n1. = altered (impaired or partial appreciation, including hyperesthesia)\n2. = normal or intact (similar as on the cheek) not testable'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Neurological Symptom Disorder', 'Paralysis', 'Conversion Disorder with Weakness/Paralysis']}, 'descriptionModule': {'briefSummary': 'In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI).\n\nThe aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects.\n\nThe overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'FND patients are recruited at the Swiss Paraplegic Centre and the Inselspital Bern. Inpatient and outpatient SCI subjects are recruited in the Swiss Paraplegic Centre .', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-65\n\nExclusion Criteria:\n\n* Contraindication for magnetic resonance examinations (e.g. cardiac pacemaker, pregnancy, etc.)\n* history of mental or neurological illness (addiction, central nervous system tumour and severe craniocerebral trauma)\n* unable to hold a pen due to paralysis'}, 'identificationModule': {'nctId': 'NCT05139732', 'briefTitle': 'Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Exploring Functional Paralysis with Advanced Magnetic Resonance Modalities', 'orgStudyIdInfo': {'id': '2021-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'Healthy participants', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)']}, {'label': 'Functional Neurological Disorder (FND)', 'description': 'People with the subtype functional paralysis', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)']}, {'label': 'Spinal Cord Injury (SCI)', 'description': 'Incomplete and complete paralysis with the ability to hold a pen', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI)']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Functional Magnetic Resonance Imaging (fMRI)', 'In-vivo Magnetic Resonance Spectroscopy (MRS)', 'Diffusion Tensor Imaging (DTI)', 'Diffusion Weighted Imaging (DWI)'], 'description': 'In order to investigate the metabolic profile, magnetic resonance spectroscopy (MRS) will be applied. Functional MRI (fMRI) allows to indirectly track cell activation measuring the blood-level dependent signal changes followed spontaneously (in resting state) or evoked by a task. Diffusion weighted imaging (DWI) is based on the differences in motion of the water molecules given by the underlying microarchitecture of the nervous tissue. Diffusion tensor imaging (DTI) allows visualisation of the nerve bundles and alterations thereof. Thus, microstructural alterations can be measured.', 'armGroupLabels': ['Functional Neurological Disorder (FND)', 'Spinal Cord Injury (SCI)', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Research', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}