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Vibrotactile Stimulation for Parkinson's Disease
N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Feels comfortable going off PD related medication during in person study visits
Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial will evaluate whether Vibrotactile Coordinated Reset stimulation (vCR), administered with the vibrotactile axon Glove, can provide relief from early stage Parkinson's symptoms. If successful, this would be a non-invasive alternative to current treatments such as levodopa and deep brain stimulation.
Who is the study for?
This trial is for English-speaking adults aged 35-90 in the U.S. with early stage Parkinson's (Hoehn and Yahr stage 1). Participants must be comfortable stopping their Parkinson's medication during visits, able to use technology for virtual meetings, and have social support if needed.Check my eligibility
What is being tested?
The study tests Vibrotactile Coordinated Reset (vCR) using a device called vibrotactile axon Glove on early-stage Parkinson's symptoms. It offers a non-invasive treatment alternative, monitoring patients over two years.See study design
What are the potential side effects?
Since vCR is non-invasive and doesn't involve drugs or surgery, side effects are minimal but may include discomfort at the glove contact points or skin irritation from prolonged use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am okay with stopping my Parkinson's disease medication for study visits.
Select...
My Parkinson's is in the early stage (stage 1).
Select...
I am between 35 and 90 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 6 months, 6 months to 12 months, 12 months to 18 months and 18 months to 24 months while patients are off mediction.
Secondary outcome measures
Gait
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Vibrotactile Coordinated Reset (vCR)Experimental Treatment1 Intervention
Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,383 Previous Clinical Trials
17,333,794 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am okay with stopping my Parkinson's disease medication for study visits.I have had brain surgery, but not just burr holes.I have someone to help me when my condition worsens.You have someone to help you if needed when you are not feeling well.I have had brain surgery.I have severe difficulty speaking or communicating.I experience excessive drooling.My Parkinson's is in the early stage (stage 1).I feel unusual sensations in my fingertips.You currently misuse drugs or alcohol.Your hairstyle prevents the EEG cap from being used.I have physical limitations not caused by Parkinson's that affect my movement.You are comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.I am between 35 and 90 years old.I have nasal problems not related to losing my sense of smell.I am willing to stop taking my brain function medication before an EEG test.You have serious mental health issues like confusion, ongoing hallucinations, or thoughts of harming yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Vibrotactile Coordinated Reset (vCR)
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.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT05545826 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you explain the age requirement for this clinical trial?
"This clinical trial is seeking participants that are aged 35 to 90."
Answered by AI
Is there still an opportunity to sign up for this research project?
"From what is posted on clinicaltrials.gov, it appears that this particular study is not currently recruiting patients. This specific trial was originally posted on October 20th, 2022 and was last updated on September 14th, 2022. There are 508 other trials that are currently looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
Colorado
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
What site did they apply to?
Stanford University
Why did patients apply to this trial?
I want an alternative to the levodopa. I still don't know if it works after 2 years into it.
PatientReceived no prior treatments
I've taken both Rasagline and Carbidopa-Levodopa, but my tremors continue to get progressively stronger.
PatientReceived no prior treatments
I’m writing on behalf of my brother in law, Gary O’Brien. He has early onset Parkinson’s and cannot take care of himself, walks it’s extreme shuffling, major hand tremors etc. He is on several medications which have made him lose a lot of weight but not improve his Parkinson’s symptoms. I heard about the gloves showing promising results and would love for Gary to try them.
PatientReceived 1 prior treatment
My symptoms continue to get worse and drugs are failing. I would very much like to get off of these drugs. I have been and continue to be willing to invest a lot of time and energy in new treatments that might make a difference in the quality of my life and the lives of those close to me. The videos and articles on Vibrotactile Coordinated Reset (vCR) sound very promising. I have been practicing mindfulness meditation for almost 50 years, and I have a natural curiosity about my mind/body.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When does the trial begin?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Stanford University: < 24 hours
Average response time
- < 1 Day
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