Trial Outcomes & Findings for Effect of CES on Parasympathetic Tone (NCT NCT02163967)
NCT ID: NCT02163967
Last Updated: 2019-10-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation
Results posted on
2019-10-11
Participant Flow
Participant milestones
| Measure |
Dose Sequence: Sham, Low, High
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
|
Dose Sequence: Sham, High, Low
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
|
Dose Sequence: Low, Sham, High
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
|
Dose Sequence; Low, High, Sham
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
|
Dose Sequence: High, Sham, Low
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
|
Dose Sequence: High, Low, Sham
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
|
|---|---|---|---|---|---|---|
|
First Intervention/ Day 1
STARTED
|
4
|
4
|
3
|
4
|
3
|
3
|
|
First Intervention/ Day 1
COMPLETED
|
4
|
4
|
3
|
4
|
3
|
3
|
|
First Intervention/ Day 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intevention/Day 2
STARTED
|
3
|
4
|
2
|
4
|
3
|
3
|
|
Second Intevention/Day 2
COMPLETED
|
3
|
4
|
2
|
4
|
3
|
3
|
|
Second Intevention/Day 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention/Day 3
STARTED
|
3
|
3
|
2
|
4
|
3
|
3
|
|
Third Intervention/Day 3
COMPLETED
|
3
|
3
|
2
|
4
|
3
|
3
|
|
Third Intervention/Day 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of CES on Parasympathetic Tone
Baseline characteristics by cohort
| Measure |
All Study Participants
n=18 Participants
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.
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulationPopulation: 3 subjects who did not complete testing sessions at all 3 stimulation doses we not included in the final analysis
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.
Outcome measures
| Measure |
Sham Stimulation
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes
|
Low Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose
|
High Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose
|
|---|---|---|---|
|
Change in High Frequency Heart Rate Variability
Baseline
|
5.10 Units on a Log Scale
Standard Error 0.40
|
5.14 Units on a Log Scale
Standard Error 0.36
|
5.00 Units on a Log Scale
Standard Error 0.43
|
|
Change in High Frequency Heart Rate Variability
Stimulation
|
5.12 Units on a Log Scale
Standard Error .25
|
5.36 Units on a Log Scale
Standard Error .23
|
5.44 Units on a Log Scale
Standard Error .27
|
|
Change in High Frequency Heart Rate Variability
Post Stimulation
|
5.12 Units on a Log Scale
Standard Error .36
|
5.40 Units on a Log Scale
Standard Error .34
|
5.46 Units on a Log Scale
Standard Error .35
|
SECONDARY outcome
Timeframe: one hourPopulation: All 21 subjects who completed at least one of the stimulation study visits are included in this analysis
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
Outcome measures
| Measure |
Sham Stimulation
n=20 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes
|
Low Dose
n=19 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose
|
High Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose
|
|---|---|---|---|
|
Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect
|
0 participants
|
8 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulationPopulation: 3 subjects who did not complete all 3 stimulation sessions were not included in the analysis
Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate
Outcome measures
| Measure |
Sham Stimulation
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes
|
Low Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose
|
High Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose
|
|---|---|---|---|
|
Change in Heart Rate
Baseline
|
70.4 beats per minute
Standard Error 1.4
|
71.8 beats per minute
Standard Error 2.1
|
73.6 beats per minute
Standard Error 1.8
|
|
Change in Heart Rate
Stimulation
|
69.4 beats per minute
Standard Error 1.3
|
70.1 beats per minute
Standard Error 2.0
|
71.4 beats per minute
Standard Error 2.1
|
|
Change in Heart Rate
Post Stimulation
|
68.3 beats per minute
Standard Error 1.2
|
69.1 beats per minute
Standard Error 1.8
|
70.7 beats per minute
Standard Error 1.8
|
SECONDARY outcome
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 stimulationPopulation: 3 enrolled subjects who did not complete all 3 stimulation sessions were not included in the analysis.
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.
Outcome measures
| Measure |
Sham Stimulation
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): sham stimulation for 20 minutes
|
Low Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose
|
High Dose
n=18 Participants
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose
|
|---|---|---|---|
|
Change in Low Frequency Heart Rate Variability
Stimulation
|
5.34 Units on a Log Scale
Standard Error 0.21
|
5.29 Units on a Log Scale
Standard Error 0.32
|
5.18 Units on a Log Scale
Standard Error 0.32
|
|
Change in Low Frequency Heart Rate Variability
Baseline
|
5.21 Units on a Log Scale
Standard Error 0.21
|
5.29 Units on a Log Scale
Standard Error 0.33
|
5.01 Units on a Log Scale
Standard Error 0.34
|
|
Change in Low Frequency Heart Rate Variability
Post-stimulation
|
5.56 Units on a Log Scale
Standard Error 0.21
|
5.43 Units on a Log Scale
Standard Error 0.30
|
5.17 Units on a Log Scale
Standard Error 0.29
|
Adverse Events
Sham
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham
n=20 participants at risk
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation
|
Low Dose
n=19 participants at risk
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 mintues, once
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation
|
High Dose
n=18 participants at risk
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation
|
|---|---|---|---|
|
Nervous system disorders
light flickering
|
0.00%
0/20 • 1 hour
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.
|
42.1%
8/19 • Number of events 8 • 1 hour
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.
|
66.7%
12/18 • Number of events 12 • 1 hour
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.
|
|
Nervous system disorders
itching or tingling of scalp
|
5.0%
1/20 • Number of events 1 • 1 hour
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.
|
26.3%
5/19 • Number of events 5 • 1 hour
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.
|
16.7%
3/18 • Number of events 3 • 1 hour
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place