This study aims to establish a protocol for the remotely supervised delivery of transcranial direct current stimulation TDCS, so that the procedure is safe, feasible, reproducible, and well tolerated. The feasibility of this protocol was tested in participants with multiple sclerosis. Transcranial direct current stimulation is a type of non-invasive brain stimulation that utilizes low amplitude direct currents to create changes in cortical excitability Treatments span weeks or months and require repeated visits to clinic, creating barriers to treatment for patients and significant provider cost.
While remote TDCS offers a convenience to both the study and administration of the therapy independent participant use is not advisable. Remote TDCS requires strict standards of use to uphold similar levels of compliance and safety observed within the clinic. The criteria which govern this study are based upon such guidelines.
This creates a setting that is an extension of the clinic rather than simply an at-home administration. These guidelines ensure TDCS research staff are trained in TDCS treatment and supervision. The user's ability to operate TDCS remotely is thoroughly assessed at baseline.
Ongoing training procedures continually support and assess the user and or caregiver device Preparation techniques are simplified to allow reproducibility and dose control for each session. Ongoing monitoring of the participant to ensure proper device preparation and confirm the appearance of any treatment emergent adverse effects. And lastly, ample instruction provided on the means to safely abort a session if need be.
Baseline screening evaluation will be composed of a physical examination and medical clearance provided by the study physician, as well as screening evaluations to gauge the participant's ability to operate study equipment. After being cleared for enrollment, participants will be familiarized with how to use the TDCS kit. The instructional video and manual provided at baseline and accessible throughout the study provide thorough and easy to comprehend instructions on materials set up administration, cleanup, and safety.
Remote monitoring of the session is achieved using secure video conferencing software, which allows the study technician to observe and interact with the participant. TDCS represents a tremendous opportunity for delivering an intervention that is well tolerated and very effective for symptom management. The effects of TDCS are thought to be cumulative for patients with motor or cognitive impairment.
It is not feasible to make repeated visits to clinic as a solution to this problem. We've developed a remotely supervised QDCS protocol. The Soxs mini CT is uniquely designed for remote delivery and requires a one-time use code provided by the study technician to unlock the device for one stimulation session.
The device will not operate without correct headset placement and will also automatically abort the session if optimal electrode contact is not maintained. The study materials are provided in a compact box, which has a detachable device holder for ease of use. The box opens to provide multiple shelves and compartments for easy storage of all materials.
A study binder is also included with the kit and contains a participant manual. This kit includes 20 individually wrapped sponge pockets with a preparation at the top 20 syringes prefilled with six milliliters of saline solution for each sponge pocket, a wash bottle filled with extra saline solution, a handheld mirror for headset application, and spare batteries for the device. The participant will then be trained by the study technician on how to properly use the TDCS device and kit.
This training will involve going over the user manual as well as the instructional video created. Specifically for this investigation, participants will first be shown an instructional video, the detailed step-by-step headset setup and placement. The study technician will also provide a realtime demonstration and assist with the participant's First attempt.
The video is accessible to the user daily. If clarification is needed, I can now put the headgear on. Make sure that the sponge pockets are against your forehead and that the back strapp is at the lower portion of your head.
Once the participant is considered to be familiar with device usage, their tolerability to the stimulation is then tested. First, the study technician will take the participant's measurements on pain and mood scales. The participant will then be asked to set up the headset for stimulation.
They must show proficiency in preparing the sponge pockets and headset electrodes. Once the participant puts on the headset, they'll be given a one minute trial dose of 1.5 milliamps of the TDCS to determine tolerability. If participants cannot tolerate the session, a lower dose of 1.0 milliamps can be applied.
If neither is tolerated, the participant is excluded. The participant's first TDCS session out of 10 will be conducted after tolerability is determined. The participant will be expected to properly use the device and will be provided with the one time use unlock code to start their stimulation.
One session will last for 20 minutes. At the end of the session, the device will beep to indicate that it can be safely removed. After the session is completed, all materials must be safely stored in the study kit.
In order to determine the feasibility of remotely supervised TDCS, the participant must independently repeat this procedure from their home. The study technician will connect remotely to the participant using a secure video conferencing software and will monitor the participant for each day of their participation. All participants for with proxy were successfully trained to selfly A-T-D-C-S session and 192 total sessions were completed.
20 of these sessions were completed during in-clinic training while 20 were completed through at-home coaching visits. Of the 152 fully remote sessions, 100%were executed correctly with successful remote application and no adverse events were reported.Results. Representative of the number of sessions successfully completed by all 20 participants is demonstrated in figure four.
Using these procedures, TDCS has the potential to become a remotely supervised therapy that upholds the standards of safety, tolerability, and compliance that are observed during in clinic TDCS administration.
