Performance Enhancing Product UseTESNCT04474015
Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment
A study testing transcranial electric stimulation in people with Performance Enhancing Product Use and Sleep, run by U.S. Army Medical Research and Development Command.
Trial summary
Transcranial electrical stimulation (TES) utilizing weak electrical fields (<5 milliamps of current - as proposed in the present pilot study) is an extremely safe therapeutic technique in use for over 40 years. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancing Product Use, Sleep
- What is being tested?
- transcranial electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2014to 12 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
About this study
Official title: Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment of Sensor (Electrode) Preparations - PARTS A, B and C
Transcranial electrical stimulation (TES) utilizing weak electrical fields (<5 milliamps of current - as proposed in the present pilot study) is an extremely safe therapeutic technique in use for over 40 years. During that time, TES has never been associated with a serious adverse event in a research setting nor a serious reported adverse event in a clinical setting. The main side effect associated with TES is irritation of the skin beneath the electrodes (as is commonly found from similar preparations used for polysomnography). The purpose of this pilot study is to identify the type of electrode preparation that maximizes subject comfort during transdermal/transcranial electrical stimulation (TES) using the NeuroConn DC Plus Stimulator.
Read the detailed description
In this study, volunteers will be divided into groups based on the nature of the stimulation waveform utilized (DC 0.75 Hz, modified AC 0.75 Hz, AC sinusoidal 3.0 Hz or pulsed stimulation of up to 500 ms duration). These waveforms were chosen based on the physiology of slow-wave sleep (SWS). Ultimately, the goal is to use TES during sleep to enhance the slow-wave activity (SWA) of sleep. Slow-wave sleep is characterized by two main frequency bands with differing underlying physiologies: (1) slow oscillation activity with a peak of 0.75 Hz, and (2) delta activity with a peak of approximately 3.0 Hz. Therefore, in future studies, the plan is to stimulate at one or both of these frequencies. The endogenous slow activity of the brain consists of electrical fields of "alternating current" with periods of relative cellular depolarization and periods of relative cellular hyperpolarization. The goal is to enhance this endogenous behavior with transcranial electrical stimulation at the two major slow- wave frequencies (0.75 Hz, 3.0 Hz), or using a pulsed stimulation paradigm to induce slow wave activity.
- Conditions
- Performance Enhancing Product Use, Sleep
- Being tested
- transcranial electric stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electric stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part A, Group 2 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part A, Group 3 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part B, Group 4 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part B, Group 5 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part B, Group 6 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
| Part C, Group 7 | Active comparator | 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. Receives: Device: transcranial electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensation scale
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
Measured: Day 1
Erythema observation
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start24 May 2014
- Primary completion12 Feb 2029 (estimated)
- Study completion12 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance Enhancing Product UseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Groups A, B and C are run sequentially.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474015
- Sponsor's protocol ID
- WRAIR #1927
- Acronym
- TES
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment of Sensor (Electrode) Preparations - PARTS A, B and C
- ClinicalTrials.gov ID
- NCT04474015
- Acronym / sponsor ID
- TES / WRAIR #1927
- Conditions
- Performance Enhancing Product Use, Sleep
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 24 May 2014 (actual)
- Primary completion
- 12 Feb 2029 (estimated)
- Study completion
- 12 Feb 2029 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial electrical stimulation (TES) utilizing weak electrical fields (<5 milliamps of current - as proposed in the present pilot study) is an extremely safe therapeutic technique in use for over 40 years. During that time, TES has never been associated with a serious adverse event in a research setting nor a serious reported adverse event in a clinical setting. The main side effect associated with TES is irritation of the skin beneath the electrodes (as is commonly found from similar preparations used for polysomnography). The purpose of this pilot study is to identify the type of electrode preparation that maximizes subject comfort during transdermal/transcranial electrical stimulation (TES) using the NeuroConn DC Plus Stimulator.
Detailed description
In this study, volunteers will be divided into groups based on the nature of the stimulation waveform utilized (DC 0.75 Hz, modified AC 0.75 Hz, AC sinusoidal 3.0 Hz or pulsed stimulation of up to 500 ms duration). These waveforms were chosen based on the physiology of slow-wave sleep (SWS). Ultimately, the goal is to use TES during sleep to enhance the slow-wave activity (SWA) of sleep. Slow-wave sleep is characterized by two main frequency bands with differing underlying physiologies: (1) slow oscillation activity with a peak of 0.75 Hz, and (2) delta activity with a peak of approximately 3.0 Hz. Therefore, in future studies, the plan is to stimulate at one or both of these frequencies. The endogenous slow activity of the brain consists of electrical fields of "alternating current" with periods of relative cellular depolarization and periods of relative cellular hyperpolarization. The goal is to enhance this endogenous behavior with transcranial electrical stimulation at the two major slow- wave frequencies (0.75 Hz, 3.0 Hz), or using a pulsed stimulation paradigm to induce slow wave activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Groups A, B and C are run sequentially.
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1 | Active comparator | Device: transcranial electric stimulationForearm 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. |
| Part A, Group 2 | Active comparator | Device: transcranial electric stimulationForearm 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. |
| Part A, Group 3 | Active comparator | Device: transcranial electric stimulationForearm 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. |
| Part B, Group 4 | Active comparator | Device: transcranial electric stimulationScalp 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. |
| Part B, Group 5 | Active comparator | Device: transcranial electric stimulationScalp 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. |
| Part B, Group 6 | Active comparator | Device: transcranial electric stimulationScalp 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. |
| Part C, Group 7 | Active comparator | Device: transcranial electric stimulationPulsed 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| transcranial electric stimulationNeuroConn® 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. | Device | Part A, Group 1, Part A, Group 2, Part A, Group 3, Part B, Group 4, Part B, Group 5, Part B, Group 6, Part C, Group 7 |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electric stimulation in people with Performance Enhancing Product Use and Sleep, run by U.S. Army Medical Research and Development Command.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Sensation scale (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.