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Behavioural Intervention
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is studying a new treatment for Parkinson's disease that uses a device to deliver vibrations to the patient's hand.
Who is the study for?
This trial is for Parkinson's Disease patients aged 35-90 in the U.S. who've had surgery (not DBS) for their condition, are comfortable with technology, and have support during off states. Excluded are those with severe psychiatric issues, substance abuse, recent or concurrent trial participation, pregnancy intentions, communication difficulties due to speech problems, excessive drooling or fingertip sensory abnormalities.Check my eligibility
What is being tested?
The study tests a non-invasive treatment called Vibrotactile Coordinated Reset (vCR), delivered through a device named vibrotactile axon Glove. It aims to offer an alternative to levodopa or deep brain stimulation for post-surgery PD patients. Participants will be monitored over two years to assess vCR's effectiveness.See study design
What are the potential side effects?
Since this is a non-drug intervention using tactile stimulation via a glove device, side effects may be minimal but could include skin irritation at contact points or temporary discomfort from the vibration stimulus.
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 24 months.
Secondary outcome measures
Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.
Gait
Levodopa equivalent daily dose (LEDD) 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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,334,040 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 35 and 92 years old.I have been diagnosed with Parkinson's disease.My Parkinson's disease symptoms are so severe that I am confined to bed.I feel unusual sensations in my fingertips.I had surgery for Parkinson's disease that wasn't Deep Brain Stimulation.I experience excessive drooling.I have severe difficulty speaking or communicating.I am receiving or have received Deep Brain Stimulation treatment.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 have someone to help me when my condition worsens.I had surgery for Parkinson's disease that wasn't deep brain stimulation.I am between 35 and 90 years old.
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: NCT05558189 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What parameters define an individual's suitability for the research endeavor?
"This parkinson disease clinical trial is only admitting 10 individuals who are between 35 and 90 years old."
Answered by AI
Does this research accept individuals who are of advanced age?
"The terms of enrolment for this trial dictacte that the youngest participant can be 35 years old and the oldest must not exceed 90."
Answered by AI
Are there vacancies in this medical experiment for participants?
"The clinicaltrials.gov records indicate that this medical study, originally posted November 20th 2022 and most recently updated September 28th 2022, is not presently recruiting patients. Currently there are 490 other studies actively looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Other
Washington
Colorado
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Stanford University
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I have faith in vibrational therapy. I really like the concept of this and focused ultrasound.
PatientReceived 2+ prior treatments
Struggling with tremors in left arm. No other symptoms so far. The trials seem to be highly effective.
PatientReceived 1 prior treatment
My husband is a stanford medicine faculty member who is very impressed with vibrotactile treatment results to date.
PatientReceived 2+ prior treatments
After taking rasagiline and carbidopa for the last two years, I’m hopeful this treatment will better control my tremors.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How often and how long are the screening visits?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Stanford University: < 48 hours
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