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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:35 - 89
Updated:7/14/2018
Start Date:November 1, 2017
End Date:July 2019
Contact:Daniella Mania
Email:Daniella.Mania@nyumc.org
Phone:646-501-4367

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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.


Inclusion Criteria:

- Diagnosis of PD confirmed by neurologist;

- Parkinson fatigue scale binary coding scoring a score of > 7;

- Able to understand the informed consent process and provide consent to participate in
the study

- Has stable and continuous access to internet service at home compatible with the study
laptop (Wi-Fi or ethernet cable)

- Adequate internet capacity for remote monitoring, as tested by
http://www.speedtest.net/)

- Subjects who are stable in their PD medication for 2 or more weeks prior to
enrollment.

Exclusion Criteria:

- Visual, auditory and motor deficits that would prevent full ability to understand
study instructions or operate the tDCS device or study laptop, as judged by treating
neurologist or study staff

- Current chronic headaches or migraines. In addition, if a subject has had a change in
the rate or severity of head pressure, headache, or migraine in the past two weeks,
they are excluded.

- History of significant head trauma (e.g., brain injury, brain surgery) or medical
device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a
Vagus Nerve Stimulator)

- Any skin disorder/sensitive skin (e.g., eczema, severe rashes, blisters, open wounds,
burn including sunburns, cuts or irritation, or other skin defects) which compromise
the integrity of the skin at or near stimulation locations where electrodes are placed

- Serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)

- Alcohol or other substance use disorder

- Hoehn and Yahr score >3

- Pregnant or breastfeeding

- History of dementia or Montreal Cognitive Assessment (MoCA) score <20

- Not capable of passing the neuropsychology /computer and tDCS aptitude test

- Unable to tolerate discomfort from the tDCS tolerability stimulation test
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Milton Biagioni, MD
Phone: 646-501-4367
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