Parkinson Disease Clinical Trial
Official title:
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
This is a double-blind randomized controlled pilot study to test the effects of
Remotely-Supervised (RS)-tDCS using a dorsolateral prefrontal cortex montage to ameliorate
fatigue and cognitive slowing in PD.
Fatigue and slowed thinking are very prevalent symptoms in people with Parkinson's disease
(PD). To date there are no concrete effective treatment available for either symptom. This
study will test transcranial direct current stimulation (tDCS) to ameliorate fatigue and
slowed thinking in PD. tDCS is a noninvasive brain stimulation technique that is low-cost,
relatively safe, and reproducible when conducted in repeat clinic visits.
Following procedures for our validated protocol, participants will receive training on the
use of study tDCS device and pre configured laptop computer. The device will be programmed to
deliver either active or sham tDCS (all study personnel and participants will be blinded),
and operated with unlock codes provided by the study technician daily to release one session.
Once trained, and following an initial in-clinic baseline tDCS tolerability test and initial
treatment session, participants will use the equipment to complete the remaining sessions
from their home using our tele medicine platform. Remote supervision will be provided using
HIPAA secure online video conference with the study technician following clearly-defined
operational procedures. Participants will be monitored to determine if any predefined "stop"
criteria are met using VSee software, a telemedicine software. Additionally, Team Viewer
software will allow study technicians to troubleshoot any computer issues, to initiate the
video conference on behalf of participants, and to remotely supervise the entire tDCS
session.
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