An interventional study of transcranial electric stimulation in Performance Enhancing Product Use and Sleep, sponsored by U.S. Army Medical Research and Development Command. Enrolling by invitation. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by U.S. Army Medical Research and Development Command · Not applicable, Interventional, and Basic science
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.
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.
U.S. Army Medical Research and Development Command is the lead sponsor of 153 studies on the registry; 8 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
Device: transcranial electric stimulation
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.
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
Time frame: 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
Time frame: Day 1
No study locations are listed for this record.
Plan to share: No
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