NCT02163967

Effect of CES on Parasympathetic Tone

Completed Phase 4 Results posted Last updated 11 October 2019

What this trial tests

Phase 4 trial testing Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) in Autonomic Nervous System Imbalance in 21 participants. Completed in 15 March 2013.

Timeline

11 January 2013

Primary endpoint
15 March 2013

15 March 2013

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	21
Start date	11 January 2013
Primary completion	15 March 2013
Estimated completion	15 March 2013
Sites	1 location across United States

Drugs / interventions tested

• Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

Conditions studied

• Autonomic Nervous System Imbalance — all drugs for Autonomic Nervous System Imbalance →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 65, any sex, with Autonomic Nervous System Imbalance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in High Frequency Heart Rate Variability Primary · 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.

Baseline

Group	Value	95% CI
Sham Stimulation	5.10	± 0.40
Low Dose	5.14	± 0.36
High Dose	5.00	± 0.43

Stimulation

Group	Value	95% CI
Sham Stimulation	5.12	± .25
Low Dose	5.36	± .23
High Dose	5.44	± .27

Post Stimulation

Group	Value	95% CI
Sham Stimulation	5.12	± .36
Low Dose	5.40	± .34
High Dose	5.46	± .35

Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect Secondary · 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

Group	Value	95% CI
Sham	0
Low Dose	8
High Dose	12

Change in Heart Rate Secondary · 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

Baseline

Group	Value	95% CI
Sham	70.4	± 1.4
Low Dose	71.8	± 2.1
High Dose	73.6	± 1.8

Stimulation

Group	Value	95% CI
Sham	69.4	± 1.3
Low Dose	70.1	± 2.0
High Dose	71.4	± 2.1

Post Stimulation

Group	Value	95% CI
Sham	68.3	± 1.2
Low Dose	69.1	± 1.8
High Dose	70.7	± 1.8

Change in Low Frequency Heart Rate Variability Secondary · 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.

Baseline

Group	Value	95% CI
Sham	5.21	± 0.21
Low Dose	5.29	± 0.33
High Dose	5.01	± 0.34

Stimulation

Group	Value	95% CI
Sham	5.34	± 0.21
Low Dose	5.29	± 0.32
High Dose	5.18	± 0.32

Post-stimulation

Group	Value	95% CI
Sham	5.56	± 0.21
Low Dose	5.43	± 0.30
High Dose	5.17	± 0.29

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 hour. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sham

Serious: 0/20 (0%)

Deaths: 0/20

Low Dose

Serious: 0/19 (0%)

Deaths: 0/19

High Dose

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (2 terms — click to expand)

Reaction	System	Sham	Low Dose	High Dose
light flickering	Nervous system disorders	—	—	—
itching or tingling of scalp	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT02163967 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124