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

NCT ID: NCT03189472

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active tDCS

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: 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)

sham tDCS

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: 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

Interventions

Active tDCS

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)

Intervention Type: DEVICE

Sham tDCS

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

Intervention Type: DEVICE

Other Intervention Names

Remotely Supervised Transcranial Direct Current Stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Drummond, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-00486

Identifier Type: -

Identifier Source: org_study_id