Effect of CES on Parasympathetic Tone

NCT ID: NCT02163967

Last Updated: 2019-10-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-11

Study Completion Date

2013-03-15

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.

Conditions

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Autonomic Nervous System Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Individual calculating heart rate and heart rate variability from ECG recordings was blind to dose of stimulation. Individual collecting side effect information was not blind to dose of stimulation.

Study Groups

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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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

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

Group Type OTHER

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Intervention Type DEVICE

low voltage alternating current transcranial electrical stimulation

Interventions

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Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

low voltage alternating current transcranial electrical stimulation

Intervention Type DEVICE

Other Intervention Names

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Fisher-Wallace Stimulator (Model FW100)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fisher Wallace Laboratories

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Altemus, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College, Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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WCMC1209013001

Identifier Type: -

Identifier Source: org_study_id

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