NCT03189472

Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease

Completed NA Last updated 21 August 2020

What this trial tests

NA trial testing Active tDCS in Parkinson Disease in 31 participants. Completed in 1 May 2020.

Timeline

1 November 2017

Primary endpoint
1 May 2020

1 May 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	31
Start date	1 November 2017
Primary completion	1 May 2020
Estimated completion	1 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Active tDCS
• Sham tDCS

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 35 to 89, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Strategies to implement and monitor in-home transcranial electrical stimulation in neurological and psychiatric patient populations: a systematic review.
   Sandran N, Hillier S, Hordacre B. · · 2019 · cited 22× · PMID 31092267 · DOI 10.1186/s12984-019-0529-5
2. Tele-monitored tDCS rehabilitation: feasibility, challenges and future perspectives in Parkinson's disease.
   Cucca A, Sharma K, Agarwal S, Feigin AS, et al · · 2019 · cited 12× · PMID 30704491 · DOI 10.1186/s12984-019-0481-4