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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_4

Timeline

Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

Study Start

First participant enrolled

January 11, 2013

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2013

Completed

1.3 years until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed

5.3 years until next milestone

Results Posted

Study results publicly available

September 19, 2019

Completed

Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

February 5, 2013

Results QC Date

August 26, 2019

Last Update Submit

October 1, 2019

Conditions

Autonomic Nervous System Imbalance

Keywords

cranial electrical stimulationCESheart rate variabilityparasympatheticVagal

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect
one hour
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
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

Study Arms (6)

Dose sequence: Sham, Low, High

OTHER

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