Effect of CES on Parasympathetic Tone

Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation

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.

Study Overview

• Status: Completed
• Conditions: Autonomic Nervous System Imbalance
• Intervention / Treatment: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteer

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dose sequence: Sham, Low, High; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)
Other: Dose sequence: Sham, High, Low; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)
Other: Dose sequence: Low, Sham, High; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)
Other: Dose sequence: Low, High, Sham; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)
Other: Dose sequence: High, Sham, Low; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)
Other: Dose sequence: High, Low, Sham; 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); low voltage alternating current transcranial electrical stimulation; Other Names: Fisher-Wallace Stimulator (Model FW100)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Fisher Wallace Laboratories
• Investigators: Principal Investigator: Margaret Altemus, MD, Weill Medical College, Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2013
• Primary Completion (Actual): March 15, 2013
• Study Completion (Actual): March 15, 2013

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: heart rate variability; CES; parasympathetic; cranial electrical stimulation; Vagal
• Other Study ID Numbers: WCMC1209013001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes