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Neurostimulation
Galvanic Stimulation for Parkinson's Disease
N/A
Recruiting
Research Sponsored by Ryan D'Arcy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must demonstrate moderate burden of motor symptoms (MDS-UPDRS part II >12 and MDS-UPDRS part III scores >35)
Must have ability to reliably use the devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4
Awards & highlights
Study Summary
This trial will help determine if multimodal non-invasive neuromodulation can help improve symptoms in PD patients.
Who is the study for?
This trial is for people with mild to moderate Parkinson's Disease (stages II-III), who are taking antiparkinsonian meds without changes in the last month, respond to oral dopamine therapy, have a certain level of cognitive function and motor symptoms. Excluded are those with atypical parkinsonism, implanted electrical devices, recent brain surgery or substance abuse issues.Check my eligibility
What is being tested?
The study tests non-invasive neuromodulation techniques—translingual neurostimulation plus/minus galvanic stimulation—combined with physical and cognitive therapy. The goal is to find effective treatment protocols for long-lasting benefits in Parkinson's patients.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort or sensitivity related to the stimulation sites (mouth area for translingual and skin behind ears for galvanic), as well as typical risks associated with physical therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have moderate motor symptoms from my condition.
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I can use the required medical devices correctly.
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I have a long-term infectious disease.
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I have issues or sensitivity in my mouth.
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My cognitive function is relatively good.
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I have been diagnosed with Parkinson's disease.
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My condition is classified as mild to moderate stage II or III.
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My high blood pressure is not under control.
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My condition improves with oral dopamine medication.
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I have had oral cancer in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MiniBESTest
NeuroCom Adaptation Test
NeuroCom Limits of Stability test (LOS)
+1 moreSecondary outcome measures
Electroencephalography - amplitudes
Electroencephalography - latencies
Montreal Cognitive Assessment (MoCA)
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Sham GVS (week 1) to active GVS (week 2)Experimental Treatment1 Intervention
Physiotherapy + translingual neurostimulation provided throughout
Group II: Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)Experimental Treatment1 Intervention
Physiotherapy + translingual neurostimulation provided throughout
Group III: Active GVS throughout weeks 1 + 2Experimental Treatment1 Intervention
Physiotherapy + translingual neurostimulation provided throughout
Group IV: Physiotherapy onlyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of British ColumbiaOTHER
1,418 Previous Clinical Trials
2,467,086 Total Patients Enrolled
Ryan D'ArcyLead Sponsor
Pacific Parkinson's Research InstituteUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a metal brain implant, recent brain surgery, or sensitive skin behind my ears.I have moderate motor symptoms from my condition.I can use the required medical devices correctly.I have not had oral surgery in the last three months.I do not have oral health issues, metal allergies, unmanaged health conditions, or a history of brain injuries that would prevent me from using the PoNS device.I have a long-term infectious disease.I am not pregnant or nursing.You have metal implants in your brain.I haven't had eye surgery in the last 3 months or ear surgery in the last 6 months.I have issues or sensitivity in my mouth.I do not have major illnesses that my doctor thinks are too risky for the trial.My cognitive function is relatively good.I have been on stable Parkinson's medication for the last 30 days.I have been diagnosed with a balance disorder.I am receiving dopamine replacement therapy through a pump.I have been diagnosed with Parkinson's disease.I have a neurological condition that is not Parkinson's disease.You experience severe episodes of freezing.You have had problems with alcohol or drug abuse in the recent past.My condition is classified as mild to moderate stage II or III.My high blood pressure is not under control.My condition improves with oral dopamine medication.I have had oral cancer in the past.You have a medical device implanted in your body.I have been diagnosed with a rare form of Parkinson's disease.I have a history of epilepsy.I have had deep brain stimulation surgery for Parkinson's disease.You have a history of serious mood or anxiety problems.
Research Study Groups:
This trial has the following groups:- Group 1: Sham GVS (week 1) to active GVS (week 2)
- Group 2: Active GVS throughout weeks 1 + 2
- Group 3: Active galvanic stimulation (GVS; week 1) to sham GVS (week 2)
- Group 4: Physiotherapy only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this clinical experiment for new participants?
"Affirmative. The clinicaltrials.gov webpage shows that recruitment for this trial began on February 9th 2022 and has recently been updated on August 8th of the same year. 32 participants are sought from one medical centre."
Answered by AI
What is the aim of this investigation?
"This experiment will use a NeuroCom Limits of Stability test to measure progress over the 4-week period. Secondary metrics like Electroencephalography latency, motor function scores from the Unified Parkinson's disease Rating Scale, and amplitudes measured with NeuroCatch Platform 2 (NCP) may also be taken into account as part of this study."
Answered by AI
To what extent is participation in this experiment open to the public?
"Affirmative. The clinicaltrials.gov website confirms that this medical research, which was inaugurated on February 9th 2022, is looking for participants. 32 individuals need to be enrolled from a single trial site."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
Washington
What site did they apply to?
Centre for Neurology Studies
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
How old are they?
65+
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Centre for Neurology Studies: < 48 hours
Average response time
- < 2 Days
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