Effect of CES on Parasympathetic Tone

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Autonomic Nervous System Imbalance

Treatments: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02163967

WCMC1209013001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteer

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 6 patient groups

Dose sequence: Sham, Low, High

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Dose sequence: Sham, High, Low

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Dose sequence: Low, Sham, High

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Dose sequence: Low, High, Sham

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Dose sequence: High, Sham, Low

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Dose sequence: High, Low, Sham

Other group

Description:

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

Treatment:

Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)