Phase 4
N=21
Effect of CES on Parasympathetic Tone
Autonomic Nervous System Imbalance
Bottom Line
View on ClinicalTrials.gov: NCT02163967 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in High Frequency Heart Rate Variability — 5.10; 5.14; 5.00; 5.12 Units on a Log Scale — p=<.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in High Frequency Heart Rate Variability |
5.10; 5.14; 5.00; 5.12; 5.36; 5.44 | <.02 sig |
| SECONDARY Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect |
0; 8; 12 | <.001 sig |
| SECONDARY Change in Heart Rate |
70.4; 71.8; 73.6; 69.4; 70.1; 71.4 | 0.81 |
| SECONDARY Change in Low Frequency Heart Rate Variability |
5.21; 5.29; 5.01; 5.34; 5.29; 5.18 | 0.47 |
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.
Eligibility Criteria
Inclusion Criteria
- healthy volunteer
Exclusion Criteria
- daily psychotropic medication,
- use of beta blocker,
- pacemaker,
- other metal in body,
- history of seizures
Data sourced from ClinicalTrials.gov (NCT02163967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.