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Effect of CES on Parasympathetic Tone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163967
Recruitment Status : Completed
First Posted : June 16, 2014
Results First Posted : September 19, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Fisher Wallace Laboratories LLC
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Imbalance Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation
Actual Study Start Date : January 11, 2013
Actual Primary Completion Date : March 15, 2013
Actual Study Completion Date : March 15, 2013

Arm Intervention/treatment
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 Name: Fisher-Wallace Stimulator (Model FW100)

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 Name: Fisher-Wallace Stimulator (Model FW100)

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 Name: Fisher-Wallace Stimulator (Model FW100)

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 Name: Fisher-Wallace Stimulator (Model FW100)

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 Name: Fisher-Wallace Stimulator (Model FW100)

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 Name: Fisher-Wallace Stimulator (Model FW100)




Primary Outcome Measures :
  1. Change in High Frequency Heart Rate Variability [ Time Frame: Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation ]
    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.


Secondary Outcome Measures :
  1. Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect [ Time Frame: one hour ]
    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

  2. Change in Heart Rate [ Time Frame: Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation ]
    Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate

  3. Change in Low Frequency Heart Rate Variability [ Time Frame: 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163967


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Fisher Wallace Laboratories LLC
Investigators
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Principal Investigator: Margaret Altemus, MD Weill Medical College, Cornell University
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02163967    
Other Study ID Numbers: WCMC1209013001
First Posted: June 16, 2014    Key Record Dates
Results First Posted: September 19, 2019
Last Update Posted: October 11, 2019
Last Verified: October 2019

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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
Keywords provided by Weill Medical College of Cornell University:
cranial electrical stimulation
CES
heart rate variability
parasympathetic
Vagal