Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT04891393
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Caffeine on Human Spinal Motoneurons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003069', 'term': 'Coffee'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motoneuron excitability (Delta-f)', 'timeFrame': 'Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention', 'description': 'Changes in motorneuron excitability, as quantified by Delta-F values. A paired motor unit technique will be utilized (Gorassini et al., 2002). (Typically, these values range from -5 to +10).'}], 'secondaryOutcomes': [{'measure': 'Motor Unit Discharge Rate', 'timeFrame': 'Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention', 'description': 'Changes in motor unit discharge rate. This is a single value that ranges from, approximately, 0 to 30.'}, {'measure': 'Coherence', 'timeFrame': 'Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention', 'description': 'Changes in coherence values. Coherence provides a normalized value of the strength of correlation in the frequency domain. The magnitude of the correlation of the Fourier transforms of two spike trains is squared producing a value between 0 and 1, with 1 corresponding to a perfect linear prediction at a particular frequency (Rosenberg et al., 1989). This will be calculated using the composite spike train (Negro \\& Farina, 2012) and, finally, z-transformed to allow for between-trial comparisons.'}, {'measure': 'Motor Unit Recruitment Threshold', 'timeFrame': 'Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention', 'description': 'Changes in motor unit recruitment threshold. As assessed by determining the amount of force (percentage of maximum volitional force output) needed to recruit an individual motor unit.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor Neuron', 'Excitability', 'Caffeine'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '11929906', 'type': 'BACKGROUND', 'citation': 'Gorassini M, Yang JF, Siu M, Bennett DJ. Intrinsic activation of human motoneurons: possible contribution to motor unit excitation. J Neurophysiol. 2002 Apr;87(4):1850-8. doi: 10.1152/jn.00024.2001.'}, {'pmid': '2682781', 'type': 'BACKGROUND', 'citation': 'Rosenberg JR, Amjad AM, Breeze P, Brillinger DR, Halliday DM. The Fourier approach to the identification of functional coupling between neuronal spike trains. Prog Biophys Mol Biol. 1989;53(1):1-31. doi: 10.1016/0079-6107(89)90004-7. No abstract available.'}, {'pmid': '23231985', 'type': 'BACKGROUND', 'citation': 'Farina D, Negro F. Accessing the neural drive to muscle and translation to neurorehabilitation technologies. IEEE Rev Biomed Eng. 2012;5:3-14. doi: 10.1109/RBME.2012.2183586.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of orally ingested, commercially available, coffee (3 mg/kg of caffeine) on the excitability of human spinal motoneurons of the lower leg.', 'detailedDescription': "Recently, it has been shown that human spinal motoneurons do not simply act as a binary control system. Instead, they are regulated by intrinsic properties that can elicit lingering effects on the descending motoneuron. Caffeine, one of the world's most popular over-the-counter supplements, can potentially augment these characteristics of motoneurons. Using decomposition software and non-invasive, high-density surface electromyography, it is possible to extract the characteristics of these motoneurons. This project will utilize a double-blind, inactive-placebo controlled, crossover design study to examine and quantify the effects of caffeine on motoneuron excitability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n● Between 18 and 70 years of age\n\nExclusion Criteria:\n\n* Significant neurological or orthopedic injuries, which may limit volitional torque generation in the tested muscles.\n* Significant change in the subjects' health or treatment in the past month.\n* Known history of cardiovascular pathology (to include: uncontrolled hypertension, cardiac arrhythmias) or medical restrictions to caffeine ingestion.\n* Allergies or dislike of coffee.\n* Women who are pregnant will be excluded due to potential forces at trunk from pelvic safety harness and due to potential adverse effects of caffeine on the developing child.\n* Women who are breastfeeding will be excluded due potential adverse effects on the breastfeeding infant from caffeine administration.\n* Adults unable to consent, minors, pregnant women, and prisoners will not be included."}, 'identificationModule': {'nctId': 'NCT04891393', 'briefTitle': 'The Effects of Caffeine on Human Spinal Motoneurons', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'The Effects of Caffeine on Human Spinal Motoneurons', 'orgStudyIdInfo': {'id': '26014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caffeine', 'description': 'Single-dose, orally ingested, instant coffee.', 'interventionNames': ['Dietary Supplement: Coffee']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive Placebo', 'description': 'Single-dose, orally ingested, instant decaffeinated coffee (equal weight to intervention dose).', 'interventionNames': ['Dietary Supplement: Decaffeinated coffee']}], 'interventions': [{'name': 'Coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Starbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg)', 'armGroupLabels': ['Caffeine']}, {'name': 'Decaffeinated coffee', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Starbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)', 'armGroupLabels': ['Inactive Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Christopher Thompson, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}