Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-21 @ 8:27 AM
Study NCT ID:
NCT02163967
Status:
COMPLETED
Last Update Posted:
2019-10-11
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of CES on Parasympathetic Tone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maltemus@med.cornell.edu', 'phone': '646-209-6277', 'title': 'Margaret Altemus', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 hour', 'description': 'Of the 21 subjects enrolled, 20 participated in the sham stimulation session, 19 participated in the low dose stimulation session and 18 participated in the high dose stimulation session.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 mintues, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 11, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 12, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'light flickering', 'notes': 'flickering light in periphery of visual field during stimulation, which is not present during post-stimulation period.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'itching or tingling of scalp', 'notes': 'sense of tingling or itching at scalp contact site of electrode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in High Frequency Heart Rate Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Stimulation', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes'}, {'id': 'OG001', 'title': 'Low Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose'}, {'id': 'OG002', 'title': 'High Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.10', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Stimulation', 'categories': [{'measurements': [{'value': '5.12', 'spread': '.25', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '.23', 'groupId': 'OG001'}, {'value': '5.44', 'spread': '.27', 'groupId': 'OG002'}]}]}, {'title': 'Post Stimulation', 'categories': [{'measurements': [{'value': '5.12', 'spread': '.36', 'groupId': 'OG000'}, {'value': '5.40', 'spread': '.34', 'groupId': 'OG001'}, {'value': '5.46', 'spread': '.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.02', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.', 'groupDescription': 'The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.'}], 'paramType': 'MEAN', 'timeFrame': 'Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'High frequency heart rate variability (HRV) will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.', 'unitOfMeasure': 'Units on a Log Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects who did not complete testing sessions at all 3 stimulation doses we not included in the final analysis'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG001', 'title': 'Low Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG002', 'title': 'High Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'one hour', 'description': 'Subjects were asked to report any side effects of the stimulation. Of all side effects reported by subjects, only light flickering in peripheral vision was endorsed by enough subjects to allow statistical analysis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 21 subjects who completed at least one of the stimulation study visits are included in this analysis'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG001', 'title': 'Low Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG002', 'title': 'High Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '70.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '71.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '73.6', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Stimulation', 'categories': [{'measurements': [{'value': '69.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': 'Post Stimulation', 'categories': [{'measurements': [{'value': '68.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '70.7', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects who did not complete all 3 stimulation sessions were not included in the analysis'}, {'type': 'SECONDARY', 'title': 'Change in Low Frequency Heart Rate Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG001', 'title': 'Low Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}, {'id': 'OG002', 'title': 'High Dose', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once\n\nCranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.21', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': 'Stimulation', 'categories': [{'measurements': [{'value': '5.34', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '5.29', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '5.18', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Post-stimulation', 'categories': [{'measurements': [{'value': '5.56', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '5.43', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '5.17', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'Low frequency heart rate variability is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'Low frequency heart rate variability will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.', 'unitOfMeasure': 'Units on a Log Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '3 enrolled subjects who did not complete all 3 stimulation sessions were not included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Sequence: Sham, Low, High', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 1milliamp stimulation intensity, Day 3 - 2 milliamp stimulation intensity'}, {'id': 'FG001', 'title': 'Dose Sequence: Sham, High, Low', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 2 milliamp stimulation intensity, Day 3 - 1 milliamp stimulation intensity'}, {'id': 'FG002', 'title': 'Dose Sequence: Low, Sham, High', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - Sham stimulation, Day 3 - 2 milliamp stimulation intensity'}, {'id': 'FG003', 'title': 'Dose Sequence; Low, High, Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - 2 milliamp stimulation intensity, Day 3 - Sham stimulation'}, {'id': 'FG004', 'title': 'Dose Sequence: High, Sham, Low', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 2 milliamp stimulation intensity , Day 2 - Sham stimulation, Day 3 - 1 milliamp stimulation intensity'}, {'id': 'FG005', 'title': 'Dose Sequence: High, Low, Sham', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 2 milliamp stimulation intensity , Day 2 - 1 milliamp stimulation intensity, Day 3 - Sham stimulation'}], 'periods': [{'title': 'First Intervention/ Day 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intevention/Day 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention/Day 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation, stimulation for 20 minutes on 3 separate days. Subjects were randomized to order of stimulation dose on the 3 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population is restricted to subjects who completed all three study sessions'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Individual calculating heart rate and heart rate variability from ECG recordings was blind to dose of stimulation. Individual collecting side effect information was not blind to dose of stimulation.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2013-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2013-02-05', 'resultsFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-26', 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in High Frequency Heart Rate Variability', 'timeFrame': 'Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'High frequency heart rate variability (HRV) will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect', 'timeFrame': 'one hour', 'description': 'Subjects were asked to report any side effects of the stimulation. Of all side effects reported by subjects, only light flickering in peripheral vision was endorsed by enough subjects to allow statistical analysis'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate'}, {'measure': 'Change in Low Frequency Heart Rate Variability', 'timeFrame': 'Low frequency heart rate variability is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation', 'description': 'Low frequency heart rate variability will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cranial electrical stimulation', 'CES', 'heart rate variability', 'parasympathetic', 'Vagal'], 'conditions': ['Autonomic Nervous System Imbalance']}, 'descriptionModule': {'briefSummary': 'The hypothesis is that CES stimulation will dose dependently increase parasympathetic tone. Healthy subjects will have three 20 minute sessions of CES stimulation, at three different intensities of stimulation, with each session occurring on a separate day. Effect on parasympathetic tone will determined by measuring high frequency heart rate variability before, during and after the stimulation. The Fisher Wallace Stimulator (FW100) which delivers a low dose alternating current a varying frequencies will be used for the stimulation.', 'detailedDescription': 'Healthy subjects will have three 20 minute sessions of bitemporal CES stimulation, at three different intensities of stimulation (sham, 1 milli Amp, 2 milli Amp), with each session occurring on a separate day. The Fisher Wallace Stimulator (FW100) which delivers a low dose alternating current a varying pulsed frequencies (5 Hertz, 500 Hertz, and 25000 Hertzz) will be used for the stimulation. ECG will be recorded continuously for 15 minutes before stimulation, during 20 minute stimulation and for 15 minutes following stimulation. Effect on parasympathetic tone will determined by measuring high frequency heart rate variability before, during and after the stimulation. Effect of CES of heart rate and low frequency heart rate variability will also be examined. Subject side effects will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer\n\nExclusion Criteria:\n\n* daily psychotropic medication,\n* use of beta blocker,\n* pacemaker,\n* other metal in body,\n* history of seizures'}, 'identificationModule': {'nctId': 'NCT02163967', 'briefTitle': 'Effect of CES on Parasympathetic Tone', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation', 'orgStudyIdInfo': {'id': 'WCMC1209013001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dose sequence: Sham, Low, High', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. Day 1- Sham stimulation; Day 2 -1 milliamp stimulation intensity, Day 3 - 2milliamp stimulation intensity', 'interventionNames': ['Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)']}, {'type': 'OTHER', 'label': 'Dose sequence: Sham, High, Low', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. Day 1- Sham stimulation; Day 2 -2 milliamp stimulation intensity, Day 3 - 1milliamp stimulation intensity', 'interventionNames': ['Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)']}, {'type': 'OTHER', 'label': 'Dose sequence: Low, Sham, High', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. Day 1- 1milliamp stimulation intensity; Day 2 -Sham stimulation; Day 3 - 2milliamp stimulation intensity', 'interventionNames': ['Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)']}, {'type': 'OTHER', 'label': 'Dose sequence: Low, High, Sham', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. Day 1- 1milliamp stimulation intensity; Day 2 - 2milliamp stimulation intensity; Day 3 - Sham stimulation', 'interventionNames': ['Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)']}, {'type': 'OTHER', 'label': 'Dose sequence: High, Sham, Low', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. Day 1- 2 milliamp stimulation intensity; Day 2 - Sham stimulation; Day 3 - 1 milliamp stimulation intensity', 'interventionNames': ['Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)']}, {'type': 'OTHER', 'label': 'Dose sequence: High, Low, Sham', 'description': 'Cranial Electrical Stimulation with Fisher-Wallace Stimulator (Model FW100) for 20 minutes on 3 separate days. 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