Effect of CES on Parasympathetic Tone

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation

Conditions
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Autonomic Nervous System Imbalance

Intervention / Treatment
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* Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteer Exclusion Criteria: daily psychotropic medication, use of beta blocker, pacemaker, other metal in body, history of seizures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dose sequence: Sham, Low, High<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|
| Other: Dose sequence: Sham, High, Low<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|
| Other: Dose sequence: Low, Sham, High<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|
| Other: Dose sequence: Low, High, Sham<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|
| Other: Dose sequence: High, Sham, Low<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|
| Other: Dose sequence: High, Low, Sham<br>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 | Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)<br>* low voltage alternating current transcranial electrical stimulation<br>* Other names: Fisher-Wallace Stimulator (Model FW100);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in High Frequency Heart Rate Variability | 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. | Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect | 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 | one hour | 
| Change in Heart Rate | Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster 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 | 
| Change in Low Frequency Heart Rate Variability | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cranial electrical stimulation, CES, heart rate variability, parasympathetic, Vagal