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

NCT03189472 | Completed

• 1 other identifier: 17-00486
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants having completed 80% sessions

  5 Weeks

Study Arms (2)

active tDCS

EXPERIMENTAL

Device: Active tDCS

sham tDCS

SHAM COMPARATOR

Device: Sham tDCS

Interventions

Active tDCS DEVICE

low amplitude direct currents to induce changes in cortical excitability. tDCS produces current intensities in the brain orders of magnitude below other stimulation techniques such as transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)

Also known as: Remotely Supervised Transcranial Direct Current Stimulation

active tDCS

Sham tDCS DEVICE

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

sham tDCS

Eligibility Criteria

• Age: 35 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Patrick Drummond, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 16, 2017
• Study Start: November 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)