Optimizing Volunteer Comfort for Transcranial Electrical Stimulation (TES): An Assessment

NCT04474015 | Enrolling By Invitation

• 1 other identifier: WRAIR #1927
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Performance Enhancing Product Use; Sleep

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Day 1

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Device: transcranial electric stimulation

Interventions

transcranial electric stimulation DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Groups A, B and C are run sequentially.

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: July 16, 2020
• Study Start: May 24, 2014
• Primary Completion (Estimated): February 12, 2029
• Study Completion (Estimated): February 12, 2029
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share