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| Name | Class |
|---|---|
| Fisher Wallace Laboratories | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) | Device | low voltage alternating current transcranial electrical stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one hour |
| Change in Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Altemus, MD | Weill Medical College, Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Sequence: Sham, Low, High | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 1milliamp stimulation intensity, Day 3 - 2 milliamp stimulation intensity |
| FG001 | Dose Sequence: Sham, High, Low | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - Sham stimulation, Day 2 - 2 milliamp stimulation intensity, Day 3 - 1 milliamp stimulation intensity |
| FG002 | Dose Sequence: Low, Sham, High | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - Sham stimulation, Day 3 - 2 milliamp stimulation intensity |
| FG003 | Dose Sequence; Low, High, Sham | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes on 3 separate days. Day 1 - 1 milliamp stimulation intensity , Day 2 - 2 milliamp stimulation intensity, Day 3 - Sham stimulation |
| FG004 | Dose Sequence: High, Sham, Low | Cranial Electrical Stimulation 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 |
| FG005 | Dose Sequence: High, Low, Sham | Cranial Electrical Stimulation 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention/ Day 1 |
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| Second Intevention/Day 2 |
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| Third Intervention/Day 3 |
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Baseline analysis population is restricted to subjects who completed all three study sessions
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation, stimulation for 20 minutes on 3 separate days. Subjects were randomized to order of stimulation dose on the 3 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 3 subjects who did not complete testing sessions at all 3 stimulation doses we not included in the final analysis | Posted | Mean | Standard Error | Units on a Log Scale | Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation |
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1 hour
Of the 21 subjects enrolled, 20 participated in the sham stimulation session, 19 participated in the low dose stimulation session and 18 participated in the high dose stimulation session.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) sham stimulation for 20 minutes, once Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| light flickering | Nervous system disorders | Non-systematic Assessment | flickering light in periphery of visual field during stimulation, which is not present during post-stimulation period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Altemus | Weill Cornell Medical College | 646-209-6277 | maltemus@med.cornell.edu |
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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.
| 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 |
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| 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 |
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Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate |
| 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. | 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 |
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| COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 1 milliamp stimulation dose |
| OG002 | High Dose | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): for 20 minutes at 2 milliamp stimulation dose |
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| Secondary | 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 | All 21 subjects who completed at least one of the stimulation study visits are included in this analysis | Posted | Number | participants | one hour |
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| Secondary | Change in Heart Rate | Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate | 3 subjects who did not complete all 3 stimulation sessions were not included in the analysis | Posted | Mean | Standard Error | beats per minute | Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation |
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| Secondary | 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. | 3 enrolled subjects who did not complete all 3 stimulation sessions were not included in the analysis. | Posted | Mean | Standard Error | Units on a Log Scale | 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 |
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| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Low Dose | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 1mAmp stimulation for 20 mintues, once Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation | 0 | 19 | 0 | 19 | 11 | 19 |
| EG002 | High Dose | Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100) 2mAmp stimulation for 20 minutes, once Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100): low voltage alternating current transcranial electrical stimulation | 0 | 18 | 0 | 18 | 12 | 18 |
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| itching or tingling of scalp | Nervous system disorders | Non-systematic Assessment | sense of tingling or itching at scalp contact site of electrode |
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| Post Stimulation |
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| Post-stimulation |
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