Effect of CES on Parasympathetic Tone

Phase 4

Completed

• Conditions: Autonomic Nervous System Imbalance
• Interventions: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

• Registration Number: NCT02163967
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01-11
• Study First Submitted: 2013-02-05
• Primary Completion: 2013-03-15
• Study Completion: 2013-03-15
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-16
• Results First Submitted: 2019-08-26
• Results First Submitted QC: 2019-08-26
• Results First Posted: 2019-09-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• healthy volunteer

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Exclusion Criteria

• daily psychotropic medication,
• use of beta blocker,
• pacemaker,
• other metal in body,
• history of seizures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dose sequence: Sham, Low, High	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	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
Dose sequence: Sham, High, Low	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	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
Dose sequence: Low, Sham, High	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	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
Dose sequence: High, Low, Sham	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	Cranial Electrical Stimulation with 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
Dose sequence: Low, High, Sham	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	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
Dose sequence: High, Sham, Low	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	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

Primary Outcome Measures

Name	Time	Method
Change in High Frequency Heart Rate Variability	Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect	one hour	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
Change in Heart Rate	Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation	Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate
Change in Low Frequency Heart Rate Variability	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	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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States