Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05225220
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multimodal Investigation of Post COVID-19 in Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D000086582', 'term': 'Anosmia'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Flanker Inhibitory Control and Attention Test (Flanker) scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "Flanker is a non-verbal NIH Toolbox Cognition Battery assessment that measures both a participant's attention and inhibitory control."}, {'measure': 'Change in Picture Sequence Memory Test (PSMT) scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "PSMT is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's episodic memory."}, {'measure': 'Change in Dimensional Change Card Sort Test (DCCS) scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "DCCS is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's executive functioning."}, {'measure': 'Change in Pattern Comparison Processing Speed scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "Pattern Comparison Processing Speed is a non-verbal NIH Toolbox Cognition Battery assessment that measures a participant's processing speed."}, {'measure': 'Change in List Sorting Working Memory scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "List Sorting Working Memory is an oral NIH Toolbox Cognition Battery assessment that measures a participant's working memory."}], 'secondaryOutcomes': [{'measure': 'Change in Magnetic Resonance Imaging (MRI)', 'timeFrame': 'At baseline and at week 3', 'description': 'MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.'}, {'measure': 'Change in resting state Electroencephalograph (EEG) signals', 'timeFrame': 'At baseline and at week 3', 'description': 'Using a 64-channel EEG system, we will perform resting-state EEG recordings to assess power spectral density changes.'}, {'measure': 'Change in blood marker levels', 'timeFrame': 'At baseline and at week 3', 'description': 'Blood markers related to COVID-19, inflammation, brain injury, and neuroplasticity will be analyzed using the Ella automated immunoassay system.'}, {'measure': 'Change in BURNS Anxiety Inventory scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': 'The BURNS Anxiety Inventory is a self-reported rating scale that measures anxiety symptoms.'}, {'measure': 'Change in Becks Depression Inventory (BDI) scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': 'The BDI is a self-reported rating inventory that measures characteristic attitudes and symptoms of depression.'}, {'measure': 'Change in PROMIS Sleep Disturbance scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': 'The PROMIS Sleep Disturbance (8b) is a self-reported measure for perception of sleep quality, depth of sleep, satisfaction with sleep, and perception of difficulty getting and staying asleep.'}, {'measure': 'Change in Fatigue Severity Scale scores', 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "The Fatigue Severity Scale is a self-reported 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders."}, {'measure': "Change in Sniffin' Sticks olfactory performance", 'timeFrame': 'At baseline, at week 3, and at week 7', 'description': "The Sniffin' Sticks test (Burghardt®, Wedel, Germany) assesses odor threshold, odor discrimination, and odor identification."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Long COVID', 'Post COVID-19 Syndrome', 'COVID long-haulers', 'Brain fog', 'Anosmia/Hyposmia', 'Neurological symptoms', 'EEG', 'MRI', 'Genetics', 'Inflammation', 'Transcutaneous vagus nerve stimulation', 'Fatigue', 'Anxiety', 'Depression', 'Cognitive impairment'], 'conditions': ['Post COVID-19', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of transcutaneous vagus nerve stimulation (t-VNS) on Long Covid symptoms in females and to identify factors influencing susceptibility and recovery-particularly in the cognitive domain, as over 80% of long-haulers experience "brain fog".', 'detailedDescription': 'Long COVID is a post-viral illness estimated to affect 10-30% of COVID-19 patients. Post-COVID symptoms can last for months and affect multiple organs. Major risk factors of long COVID include the female sex and pre-existing anxiety/depression. Because women already have higher rates of anxiety/depression, the combined risks could exacerbate their susceptibility.\n\nBased on the rationale that long COVID symptoms significantly overlap with functions of the vagus nerve, which serves as a conduit between the brain and body, the investigators propose to use non-invasive transcutaneous vagus nerve stimulation (t-VNS) as a novel treatment for long COVID in 20 female participants.\n\nThis pilot study will utilize a holistic approach by integrating neuromodulation, neuroimaging, genetics, blood biomarkers, behavioral assessments, and wearable technology to examine the effects of VNS therapy on post COVID-19 symptoms and to identify factors that influence susceptibility and recovery, particularly in the cognitive domain, as over 80% of long-haulers report experiencing "brain fog" (i.e., cognitive disruptions).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants must be of female sex at birth and at time of study enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biologically female at birth and at time of enrollment\n* At least 18 years of age or older\n* Experiencing persistent symptoms of brain fog/cognitive impairment beyond 3 months of COVID-19 infection that are not explained by an alternative diagnosis\n\nExclusion Criteria:\n\n* Not t-VNS compatible (e.g. pacemaker implants)\n* Not MRI compatible (e.g. metal implants, claustrophobia)\n* Currently pregnant\n* Long COVID without cognitive impairment\n* History of neurological conditions prior to COVID-19 infection'}, 'identificationModule': {'nctId': 'NCT05225220', 'briefTitle': 'Multimodal Investigation of Post COVID-19 in Females', 'organization': {'class': 'OTHER', 'fullName': 'Casa Colina Hospital and Centers for Healthcare'}, 'officialTitle': 'Multimodal Investigation of Post COVID-19 in Females: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB#00002372'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Vagus Nerve Stimulation (t-VNS)', 'description': 'Participants will receive 60 minutes of t-VNS stimulation every day for 10 consecutive days while wearing a fitness tracker.', 'interventionNames': ['Device: Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)']}], 'interventions': [{'name': 'Parasym Device (of Parasym Ltd, UK) using Transcutaneous Vagus Nerve Stimulation (t-VNS)', 'type': 'DEVICE', 'description': 'Electrode clip will be placed on the left ear.', 'armGroupLabels': ['Transcutaneous Vagus Nerve Stimulation (t-VNS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91769', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Casa Colina Hospital and Centers for Healthcare', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}], 'overallOfficials': [{'name': 'Amy Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Casa Colina Hospital and Centers for Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa Colina Hospital and Centers for Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Amy Zheng', 'investigatorAffiliation': 'Casa Colina Hospital and Centers for Healthcare'}}}}