Back to resultsRemotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active tDCS
sham tDCS
Arm Description
Outcomes
Primary Outcome Measures
Number of participants having completed 80% sessions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189472
Brief Title
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
Official Title
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active tDCS
Arm Type
Experimental
Arm Title
sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Remotely Supervised Transcranial Direct Current Stimulation
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of participants having completed 80% sessions
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Drummond, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
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