Effect of CES on Parasympathetic Tone

Autonomic Nervous System Imbalance Clinical Trial

Official title:

Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163967
• Other study ID #: WCMC1209013001
• Status: Completed
• Phase: Phase 4
• Start date: January 11, 2013
• Est. completion date: March 15, 2013

Study information

• Verified date: October 2019
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 15, 2013
• Est. primary completion date: March 15, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy volunteer

Exclusion Criteria:

• daily psychotropic medication,

• use of beta blocker,

• pacemaker,

• other metal in body,

• history of seizures

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance

Intervention

Device:
• Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
low voltage alternating current transcranial electrical stimulation

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Fisher Wallace Laboratories LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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