Presentation on supervised remote delivery of tDCS as clinical trial extension

1. Remotely-Supervised Transcranial
Direct Current Stimulation (tDCS)
Leigh Charvet1, Margaret Kasschau1, Marom Bikson2, Abhishek Datta7,
Helena Knotkova3, Michael C. Stevens4, Angelo Alonzo5, Colleen Loo5,
Kevin Krull6, Lamia Haider1
1 Department of Neurology, Stony Brook Medicine
2 Department of Biomedical Engineering, The City College of New York
3 MJHS Institute for Innovation in Palliative Care, New York
4 Olin Neuropsychiatry Research Center, Yale University School of Medicine
5 School of Psychiatry, University of New South Wales; Black Dog Institute
6 St. Jude Children’s Research Hospital, Memphis, Tennessee
7 Soterix Medical Inc., New York

2. Remote tDCS Delivery
• Obstacle of travel to clinic for tDCS delivery
– Burden to patients and caregivers, cost
– Can limit reach, size and length of clinical trials
• Supervised remote delivery of tDCS as
clinical trial extension
– Diverse group of interested investigators
– Goal to maintain the standards of clinic delivery

3. Standards for Technology and
Study Protocols
1) Training of tDCS research staff
2) Initial and ongoing assessment of the user’s capability to participate
3) Supportive training procedures and materials (including assessment
of the caregiver)
4) Simple and fail-safe electrode preparation and positioning
5) Strict dose control for each session
6) Ongoing monitoring for compliance
7) Ongoing monitoring for treatment-emerging adverse effects
8) Guidance to identify and implement discontinuation of a session
and/or study participation (including emergency failsafe procedures)
tailored to the treatment population’s level of need