NCT02163967

Effect of CES on Parasympathetic Tone

Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autonomic Nervous System Imbalance

Interventions

Type	Name	Description
DEVICE	Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)	low voltage alternating current transcranial electrical stimulation

Timeline

• Start date: 2013-01-11
• Primary completion: 2013-03-15
• Completion: 2013-03-15
• First posted: 2014-06-16
• Last updated: 2019-10-11
• Results posted: 2019-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study