Document Type
Article
Publication Date
4-22-2022
Abstract
Introduction: The ability to deploy transcranial direct current stimulation (tDCS) at home is a key usability advantage to support scaling for pivotal clinical trials. We have established a home-based tDCS protocol for use in clinical trials termed remotely supervised (RS)-tDCS.
Objective: To report the tolerability and feasibility of tDCS sessions completed to date using RS-tDCS in clinical trials.
Methods: We analyzed tolerability (i.e., adverse events, AEs) reported in six Class I/II/III trials using RS-tDCS to study symptom outcomes over 10 to 60 daily applications. Across the six clinical trials, 308 participants (18-78 years old) completed an average of 23 sessions for a total of 6779 RS-tDCS administrations. The majority of participants were diagnosed with multiple sclerosis, and open-label trials included those diagnosed with a range of other conditions (e.g., Parkinson's disease, post-stroke aphasia, traumatic brain injury, cerebellar ataxia), with minimum-to-severe neurologic disability. Clinical trial feasibility (i.e., treatment fidelity and blinding integrity) was examined using two Class I randomized controlled trials (RCTs).
Results: No serious AEs occurred. Across administrations, three sessions (0.04%) were aborted due to discomfort, but no participant discontinued due to tolerability. The AEs most commonly reported by participants were tingling (68%), itching (41%) and warmth sensation (42%) at the electrode site, and these were equally reported in active and sham tDCS conditions. The two Class I RCTs resulted in rapid enrollment, high fidelity to treatment completion, and blinding integrity.
Conclusions: At-home RS-tDCS is tolerable, including when used over extended periods of time. Home-based RS-tDCS is feasible and can enable Class I tDCS clinical trial designs.
Recommended Citation
Pilloni, Giuseppina; Vogel-Eyny, Amy; Lustberg, Matthew; Best, Pamela; Malik, Martin; Walton-Masters, Lillian; George, Allan; Mirza, Ibraheem; Zhovtis, Lana; Datta, Abhishek; Bikson, Marom; Krupp, Lauren; and Charvet, Leigh, "Tolerability and feasibility of at-home remotely supervised transcranial direct current stimulation (RS-tDCS): Single-center evidence from 6,779 sessions" (2022). Department of Medicine Faculty Papers. Paper 360.
https://jdc.jefferson.edu/medfp/360
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
35470019
Language
English
Comments
This article is the author’s final published version in Brain Stimulation, Volume 15, Issue 3, April 2022, Pages 707 - 716.
The published version is available at https://doi.org/10.1016/j.brs.2022.04.014. Copyright © Pilloni et al.