Parkinson DiseaseNCT03189472
Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
A study testing Active tDCS in people with Parkinson Disease, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 89 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Active tDCS, Sham tDCS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Remotely Supervised Transcranial Direct Current Stimulation
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 tDCSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Not described Receives: Device: Active tDCS |
| sham tDCS | Sham comparator | Not described Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants having completed 80% sessions
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Nov 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Drummond, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189472
- Sponsor's protocol ID
- 17-00486
- Status last verified
- Aug 2020
- First submitted
- 5 Jun 2017
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely-supervised Transcranial Direct Current Stimulation (tDCS) for At-home Treatment of Fatigue and Cognitive Slowing in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03189472
- Acronym / sponsor ID
- 17-00486
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: Active tDCS |
| sham tDCS | Sham comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 35 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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/)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSAlso: Remotely Supervised Transcranial Direct Current Stimulationlow 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) | Device | active tDCS |
| Sham tDCSThe 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 | Device | sham tDCS |
Primary outcome
Number of participants having completed 80% sessions
Time frame: 5 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Drummond, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Parkinson Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants having completed 80% sessions (time frame: 5 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.