Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT06358560
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'There are 10 questions that are answered on a scale of 1-5, for a final score ranging from 10-50. The higher the number the worse the outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The investigators will recruit the first 5-15 people that present to the clinic on their own for treatment for 'stress'.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must be 18 years of age or older.\n* Must be presenting to the clinic for treatment for 'stress'.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* No vulnerable populations (physical or mental disability, economically or educationally disadvantaged, pregnancy, minors, persons incarcerated).\n* No participants that have an additional relationship beyond the doctor/patient relationship that exists by nature of a patient committing to treatment (a family member or clinic employee would be excluded from the study)."}, 'identificationModule': {'nctId': 'NCT06358560', 'briefTitle': 'Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers', 'organization': {'class': 'OTHER', 'fullName': 'The Brain Health Clinics'}, 'officialTitle': 'Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers', 'orgStudyIdInfo': {'id': 'BrainHealthClinics'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Therapeutic exercises', 'type': 'OTHER', 'description': 'Rehabilitation exercises designed to achieve the treatment goal'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37217', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tyler Hurst, DC', 'role': 'CONTACT', 'email': 'drhurst@thebrainhealthclinics.com', 'phone': '615-922-0977'}, {'name': 'Dylan Saulsbery, DC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tyler Hurst, DC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dominic Fetterly, DC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Brain Health Clinics', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Dylan Saulsbery, DC', 'role': 'CONTACT', 'email': 'admin@thebrainhealthclinics.com', 'phone': '4129999934'}, {'name': 'Tyler Hurst, DC', 'role': 'CONTACT', 'email': 'drhurst@thebrainhealthclinics.com', 'phone': '6159220977'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dylan Saulsbery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Dylan Saulsbery', 'investigatorAffiliation': 'The Brain Health Clinics'}}}}