Clinical trial NCT02163967: Effect of CES on Parasympathetic Tone
Official title: Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autonomic Nervous System Imbalance
Keywords: cranial electrical stimulation
CES
heart rate variability
parasympathetic
Vagal
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Fisher Wallace Laboratories
First posted: 2014-06-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer

Exclusion Criteria:

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

Primary outcomes:
measure: Change in High Frequency Heart Rate Variability
timeFrame: 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:
measure: Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect
timeFrame: one hour
measure: Change in Heart Rate
timeFrame: Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation
measure: Change in Low Frequency Heart Rate Variability
timeFrame: 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
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College, Cornell University
name: Margaret Altemus, MD
role: PRINCIPAL_INVESTIGATOR
References: