Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 12:10 PM
Study NCT ID:
NCT04058457
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DBS and Respiration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in breathlessness', 'timeFrame': 'Pre-operatively and post-operatively (6-months)', 'description': 'Dyspnoea questionnaire (D12, MRC)'}, {'measure': 'Change in breathlessness', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.'}], 'secondaryOutcomes': [{'measure': 'Change in pulmonary function', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Spirometry'}, {'measure': 'Change in airways resistance', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Oscillometry'}, {'measure': 'Change in respiratory muscle strength', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Maximum inspiratory/expiratory pressures'}, {'measure': 'Change in surface electromyography of respiratory muscles', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Signal analysis for evidence of tremor'}, {'measure': 'Change in hypercapnic ventilatory response', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Changes in ventilation from incrementally increased inhaled CO2'}, {'measure': 'Change in breath-hold', 'timeFrame': 'ON and OFF stimulation between 1 and 6 months after surgery', 'description': 'Dyspnoea threshold and breakpoint'}, {'measure': 'Change in daily activity', 'timeFrame': 'Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)', 'description': 'Pedometry'}, {'measure': 'Change in daily activity', 'timeFrame': 'Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)', 'description': 'Heart rate'}, {'measure': 'MRI structural connectivity', 'timeFrame': 'Pre-operative scan with post-operative analysis through study completion at an average of 1 year', 'description': 'DTI correlation with respiratory outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'movement disorder', 'dyspnoea', 'dyspnea', 'breathlessness', 'respiratory'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease.\n\nThe investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.", 'detailedDescription': 'A continuous cohort of Parkinson disease patients planned to undergo STN-DBS will be approached to participate in this study (i.e. every patient will be offered participation in the study). Over the same time period other DBS patients (GPi and VIM) will be approached before their implantation procedure to participate as controls/comparators. Participants will all be offered the full study, but will also be free to participate in a smaller number of activities if so chosen.\n\nPatients will be assessed both pre-operatively and post-operatively where they will complete a compound respiratory questionnaire and tests of respiratory interoception and function. Post-operatively, these tests will be carried out with stimulation ON and OFF, the order of which will be randomised between patients.\n\nData on daily activity will be collected during pre- and post-operative windows, using a wearable pedometer/heart-rate monitor.\n\nPositive findings of respiratory neuromodulation will be correlated between patients with structural connectivity (e.g. STN-insula.) from pre-operative MRI scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or female, aged 18 years or above.\n* Planned for required DBS surgery\n* Fluent in the English language\n* For experimental group: diagnosed with Parkinson's disease\n\nExclusion Criteria:\n\n* Female who is pregnant\n* Subject is currently participating in a clinical investigation that includes an active treatment arm which may affect the respiratory system.\n* Acute respiratory problem at time of experimental session: e.g. rhinosinusitis, pharyngitis, asthma exacerbation"}, 'identificationModule': {'nctId': 'NCT04058457', 'briefTitle': 'DBS and Respiration', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': "Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing", 'orgStudyIdInfo': {'id': '256825'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STN DBS', 'description': 'Patients planned to undergo deep brain stimulation of the subthalamic nucleus', 'interventionNames': ['Device: DBS']}, {'label': 'GPi DBS', 'description': 'Patients planned to undergo deep brain stimulation of the globus pallidus interna', 'interventionNames': ['Device: DBS']}, {'label': 'VIM DBS', 'description': 'Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus.', 'interventionNames': ['Device: DBS']}], 'interventions': [{'name': 'DBS', 'type': 'DEVICE', 'description': 'Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF. DBS implantation itself is part of routine care, and not part of the study.', 'armGroupLabels': ['GPi DBS', 'STN DBS', 'VIM DBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alex Green, FRCS', 'role': 'CONTACT', 'email': 'alex.green@nds.ox.ac.uk', 'phone': '01865234762'}], 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Alex Green, FRCS', 'role': 'CONTACT', 'email': 'alex.green@nds.ox.ac.uk', 'phone': '01865227645', 'phoneExt': '+44'}], 'overallOfficials': [{'name': 'Alex Green, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oxford Brookes University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}