Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 6:25 AM
Study NCT ID:
NCT07082595
Status:
RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional walking ability', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'the change in functional walking ability assessed with the 6-minute walk test (6MWT)'}, {'measure': 'postural stability', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'the change in postural stability assessed with the MiniBEST test measured before and after the intervention period.'}], 'secondaryOutcomes': [{'measure': 'Phase Coordination Index', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'Motor learning assessed via changes in coordination. Coordination assessed using the Phase Coordination Index.'}, {'measure': 'Continuous Relative Phase', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'Motor learning assessed via changes in coordination. Coordination assessed using Continous Relative Phase.'}, {'measure': 'Variability', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'Motor learning assessed via changes in variability. Variability assessed using the coefficient of variation (%CV) of common spatio-temporal gait parameters, including stride time, stride length, step length, swing time, stance time, step width, and double limb support time.'}, {'measure': 'Symmetry', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'Motor learning assessed via changes in symmetry. Symmetry (%) in step length and step time.'}, {'measure': 'Margin of Stability', 'timeFrame': 'Baseline, one to three days after the last intervention day (post-assessment), one month after the last intervention day (follow-up assessment).', 'description': 'Motor learning assessed via changes in stability. Stability assessed using Margin of Stability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Sleep', 'Neurorehabilitation', 'Auditory stimulation', 'StimuLOOP'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a neurodegenerative disease that affects about 1% of the elderly population and accounts for substantial disability and health care costs. Disability is largely driven by mobility deficits caused by impaired gait. Effective treatments are available to restore lower limb function and improve gait, but response to treatment varies greatly from patient to patient and often shows only small effect sizes. Addressing this heterogeneity requires personalization, a concept referred to precision neurorehabilitation.\n\nStimuLOOP.PD-Sleep intends to foster structured and reproducible methods for precision neurorehabilitation of gait in PD. The investigators will conduct a proof-of-concept study to investigate a sleep intervention tailored to the individual patient in the context of motor rehabilitation.\n\n• Targeted auditory stimulation during sleep (TASS): The investigators aim to reactive rehabilitation-related memories through presentation of auditory stimuli during sleep with the goal of promoting motor memory consolidation into stable motor commands.\n\nThe investigators will leverage TASS to enhance consolidation of the movement patterns that are learned during rehabilitation.\n\nThe investigators expect that this intervention will lead to greater gains in functional walking ability and balance. Beyond demonstrating a proof-of-concept for novel methods of applying TASS stimulation in the context of neurorehabilitation, positive results of this project may have implications for neurorehabilitation treatment in general by providing first insights into the benefits and interplay of TASS with a rehabilitation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic Parkinson's disease with gait and postural stability deficits\n* ≥18 years of age\n* UPDRS III gait scores 1-3\n* UPDRS III postural instability scores 1-3\n* Prescribed rehabilitation therapy\n* Informed consent as documented by signature\n* Adjustments in dopaminergic medication and DBS stimulation to improve\n\nExclusion Criteria:\n\n* Cognitive impairment, Montreal Cognitive Assessment (MoCa) \\< 20\n* Other neurological or medical condition that caused sustained clinically relevant gait and/or postural stability deficits\n* History of a physical or neurological condition that interferes with study procedures\n* Social and/or personal circumstances that interfere with the ability to return for assessments\n* Patients taking benzodiazepines or Z-drugs that have a significant effect on sleep EEG\n* Recent DBS implant (≤ 6 months)\n* Inability to perform outcome assessments without walking aid\n* Skin disorders/problems/allergies in face/ear area that could worsen with electrode application (e.g. nickel allergy)"}, 'identificationModule': {'nctId': 'NCT07082595', 'acronym': 'StimuLOOP_PD-S', 'briefTitle': 'Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Personalized Stimulation Loop for Neurorehabilitation in Parkinson: a Proof-of-principle Study', 'orgStudyIdInfo': {'id': 'StimuLOOP_PD-S'}, 'secondaryIdInfos': [{'id': '2024-01941', 'type': 'OTHER', 'domain': 'BASEC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham arm', 'description': 'Control targeted auditory stimulation during sleep during motor rehabilitation (TASS sham intervention)', 'interventionNames': ['Other: TASS Intervention (Sham)']}, {'type': 'EXPERIMENTAL', 'label': 'Verum arm', 'description': 'Targeted auditory stimulation during sleep during motor rehabilitation (TASS verum intervention)', 'interventionNames': ['Other: TASS Intervention (Verum)']}], 'interventions': [{'name': 'TASS Intervention (Sham)', 'type': 'OTHER', 'description': 'Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. No auditory stimuli will be delivered.', 'armGroupLabels': ['Sham arm']}, {'name': 'TASS Intervention (Verum)', 'type': 'OTHER', 'description': 'TASS: Participants will sleep with the portable EEG (TSB, Axo, Tosoo AG, Zurich, CH) during 15 days of their regular motor rehabilitation. Auditory stimuli will be delivered through the integrated headphones when non-rapid-eye-movement (NREM) sleep is detected during the night to induce TASS.', 'armGroupLabels': ['Verum arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Angelina Maric, Dr. phil.', 'role': 'CONTACT', 'email': 'angelina.maric@usz.ch', 'phone': '+41 255 86 15'}, {'name': 'Yannik Rottenberger, MSc', 'role': 'CONTACT', 'email': 'yannik.rottenberger@usz.ch', 'phone': '+41 255 56 45'}, {'name': 'Angelina Maric, Dr. phil.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William R. Taylor, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Christian Baumann, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'christian.baumann@usz.ch', 'phone': '+41 44 255 00 02'}, {'name': 'Angelina Maric, Dr. phil.', 'role': 'CONTACT', 'email': 'angelina.maric@usz.ch', 'phone': '+ 41 255 86 15'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich (Switzerland)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}