Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment (TES)
Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment of Sensor (Electrode) Preparations - PARTS A, B and C
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria - healthy adult men and non-pregnant, non-lactating women aged 18-39 years, inclusive.
Exclusion criteria - The following exclusion criteria apply to all volunteers, are consistent with those used in our other sleep studies, and are applied in this protocol in order to obtain a sample of volunteers who are likely to be representative of future study populations:
- Self-reported habitual nightly sleep amounts outside the target range of 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, on average):
- Nighttime lights-out times earlier than 2100 hours on average during weeknights (Sunday through Thursday) for the past month
- Morning wake-up times later than 0900 on average during weekdays (Monday through Friday) for the past month.
- History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)
- Reported habitual napping (> 3 times a week in conjunction with normal sleep habits)
- Resting blood pressure above 140/90
- Resting pulse > 110
- Neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders)
- Kidney disease
- History of psychiatric disorder requiring hospitalization or psychiatric medication for any length of time
- Beck Depression Inventory score of 14 or above
- Underlying pulmonary disease requiring daily inhaler use
- Regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 1 year
- Positive nicotine/cotinine screen as determined by NicCheck™ I test strips
- Heavy alcohol use to be determined by the PI or his/her representative (minimum limit to define heavy alcohol use is 14 drinks per week)
- Use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
- Known liver disease or liver abnormalities as determined by a laboratory test
- Self-reported history of caffeine use in excess of 400 mg (approximately 8 caffeinated sodas or 3-4 cups of coffee) per day on average
- Pregnancy (females)
- Inability to read and sign consent
- Use of certain medications (including use of vitamins or supplements), to be determined on a case-by-case basis by the examining study licensed physician.
- BMI ≥ 30 (Obese Class I or greater)
- The PI also maintains the prerogative to disqualify a volunteer if it is deemed that the volunteer's participation would be unsafe for the volunteer or staff or would be disruptive to study conduct.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Part A, Group 1
Forearm stimulation during wake (study PART A) - electrode placement = volar surface of forearm, 2 electrodes (cathode and anode): Group 1 will receive forearm stimulation at 0.75 Hz with an oscillating direct current (DC) waveform while awake.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part A, Group 2
Forearm stimulation during wake (study PART A) - electrode placement = volar surface of forearm, 2 electrodes (cathode and anode): Group 2 will receive forearm stimulation at 0.75 Hz with a modified alternating current (AC) waveform while awake.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part A, Group 3
Forearm stimulation during wake (study PART A) - electrode placement = volar surface of forearm, 2 electrodes (cathode and anode): Group 3 will receive forearm stimulation at 3.0 Hz with an alternating current (AC) sinusoidal waveform while awake.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part B, Group 4
Scalp stimulation during sleep (study PART B) - bilateral electrode pairs placed on the upper forehead near the midline (F3 and F4) and adjacent to the ear in the mastoid region (M1 and M2).
roup 4 will receive scalp stimulation at 0.75 Hz with an oscillating direct current (DC) waveform during sleep.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part B, Group 5
Scalp stimulation during sleep (study PART B) - bilateral electrode pairs placed on the upper forehead near the midline (F3 and F4) and adjacent to the ear in the mastoid region (M1 and M2).
Group 5 will receive scalp stimulation at 0.75 Hz with a modified alternating current (AC) waveform during sleep.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part B, Group 6
Scalp stimulation during sleep (study PART B) - bilateral electrode pairs placed on the upper forehead near the midline (F3 and F4) and adjacent to the ear in the mastoid region (M1 and M2).
Group 6 will receive scalp stimulation at 3.0 Hz with an alternating current (AC) sinusoidal waveform during sleep.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
|
Active Comparator: Part C, Group 7
Pulsed Stimulation: Group 7 (Part C)will receive a series of brief stimulations of up to 500 millisecond duration and of up to 5 milliamperes of current, using either metal electrodes or sponge electrodes as stimulating electrodes.
|
NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz.
This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz.
Also, the NeuroConn only allows low current intensities to be chosen.
The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensation scale
Time Frame: Day 1
|
participants indicate level of sensation on a scale from 1-10; Sensation Scale: 0 to 10 where 10 indicates experiencing severe discomfort; 0 indicates no discomfort
|
Day 1
|
|
Erythema observation
Time Frame: Day 1
|
observation of skin erythema following removal of electrodes: At baseline observation for presence of skin lesions/pathology; following stimulation observation of a change or no change in skin lesions/pathology from baseline
|
Day 1
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- WRAIR #1927
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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