Autonomic Nervous System ImbalancePhase 4NCT02163967

Effect of CES on Parasympathetic Tone

A Phase 4 study testing Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) in people with Autonomic Nervous System Imbalance, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Autonomic Nervous System Imbalance
What is being tested?: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2013to 15 Mar 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

healthy volunteer

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medical College
New York, New York, 10065

Other trials in United States

About this study

Official title: Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation

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.

Read the 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.

Conditions: Autonomic Nervous System Imbalance
Being tested: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Keywords: cranial electrical stimulation, CES, heart rate variability, parasympathetic, Vagal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)Device
Also called Fisher-Wallace Stimulator (Model FW100)
low voltage alternating current transcranial electrical stimulation

Study groups in NCT02163967
Study group	Role	What they receive
Dose sequence: Sham, Low, High	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Dose sequence: Sham, High, Low	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Dose sequence: Low, Sham, High	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Dose sequence: Low, High, Sham	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Dose sequence: High, Sham, Low	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)
Dose sequence: High, Low, Sham	Other	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 Receives: Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in High Frequency Heart Rate Variability
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.
Measured: 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 (3)

Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect
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
Measured: one hour
Change in Heart Rate
Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate
Measured: Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation
Change in Low Frequency Heart Rate Variability
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 201315 Mar 2013

First posted16 Jun 2014 (estimated)
Study start11 Jan 2013
Primary completion15 Mar 2013
Study completion15 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02163967
Sponsor's protocol ID: WCMC1209013001
Status last verified: Oct 2019
First submitted: 5 Feb 2013
Last updated: 11 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autonomic Nervous System Imbalance trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Cranial Electrical Stimulation (CES) on Autonomic Regulation
ClinicalTrials.gov ID: NCT02163967
Acronym / sponsor ID: WCMC1209013001
Conditions: Autonomic Nervous System Imbalance
Keywords: cranial electrical stimulation, CES, heart rate variability, parasympathetic, Vagal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Fisher Wallace Laboratories
Study start: 11 Jan 2013 (actual)
Primary completion: 15 Mar 2013 (actual)
Study completion: 15 Mar 2013 (actual)
First posted: 16 Jun 2014 (estimated)
Results: Posted 19 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Dose sequence: Sham, Low, High	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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
Dose sequence: Sham, High, Low	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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
Dose sequence: Low, Sham, High	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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
Dose sequence: Low, High, Sham	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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
Dose sequence: High, Sham, Low	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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
Dose sequence: High, Low, Sham	Other	Device: Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

healthy volunteer

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)Also: Fisher-Wallace Stimulator (Model FW100)low voltage alternating current transcranial electrical stimulation	Device	Dose sequence: High, Low, Sham, Dose sequence: High, Sham, Low, Dose sequence: Low, High, Sham, Dose sequence: Low, Sham, High, Dose sequence: Sham, High, Low, Dose sequence: Sham, Low, High

Primary outcome

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.

3 secondary outcomes

Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect
Time frame: one hour
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
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

Results and safety

Results posted to the registry on 19 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Sequence: Sham, Low, High	4	4
Dose Sequence: Sham, High, Low	4	4
Dose Sequence: Low, Sham, High	3	3
Dose Sequence; Low, High, Sham	4	4
Dose Sequence: High, Sham, Low	3	3
Dose Sequence: High, Low, Sham	3	3

Primary outcome: 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. Mean (Standard Error). Unit: Units on a Log Scale

Measure	Sham Stimulation n = 18	Low Dose n = 18	High Dose n = 18
Baseline	5.10 (0.40)	5.14 (0.36)	5.00 (0.43)
Stimulation	5.12 (.25)	5.36 (.23)	5.44 (.27)
Post Stimulation	5.12 (.36)	5.40 (.34)	5.46 (.35)

Sham Stimulation vs Low Dose vs High Dose: p <.02, Regression, Linear

Population analysed: 3 subjects who did not complete testing sessions at all 3 stimulation doses we not included in the final analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 hour. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Low Dose	0 of 19 (0%)	11 of 19 (57.9%)	0 of 19
High Dose	0 of 18 (0%)	12 of 18 (66.7%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Altemus, MD principal investigator

Weill Medical College, Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.