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Behavioural Intervention
Non-Invasive Vibration Therapy 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 baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a non-invasive device to reduce Parkinson's symptoms. Patients will be monitored for two years to see if the device works.
Who is the study for?
This trial is for people aged 35-90 with advanced Parkinson's Disease (stages 2 to 4), who are comfortable with technology and can manage without certain brain function medications during EEG recordings. They must not be pregnant, involved in other trials recently, have a history of significant brain surgery or severe psychiatric issues, or substance abuse problems.
What is being tested?
The study tests Vibrotactile Coordinated Reset stimulation using the vibrotactile axon Glove on Parkinson's symptoms. It offers a non-invasive treatment alternative to levodopa or deep brain stimulation and monitors patients over two years.
What are the potential side effects?
Potential side effects aren't specified but as vCR is non-invasive and doesn't involve drugs, it may be associated with less risk than medication or surgical options. However, discomfort from glove use or skin irritation could occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
Secondary study objectives
Communicative Participation Item Bank (CPIB; Short Form)
Freezing of Gait Questionnaire (FOG)
Levodopa equivalent daily dose (LEDD)
+9 moreOther study objectives
Quantitative Digitography Repetitive Alternating Finger Task (QDG-RAFT)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
2,468 Previous Clinical Trials
17,496,247 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have someone to help me when my condition worsens.I have had brain surgery.I have had brain surgery.I am between 35 and 92 years old.I have physical issues not related to Parkinson's that affect my movement.I am willing to stop my brain-related medication before an EEG test.I have severe difficulty communicating verbally.I experience excessive drooling.My Parkinson's is at a moderate stage, not too mild or too severe.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.
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: NCT05504902 — N/A
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