Back to resultsVibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stanford Glove
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: Ages 18 or older Diagnosed with idiopathic Parkinson's Disease Fluent in English Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit. Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures. Exclusion Criteria: Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators. Pregnancy, breast-feeding or wanting to become pregnant Physical limitations unrelated to PD that would affect motor ratings Has implantation of a medical device Sensory abnormalities of the fingertips
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active stimulation
Sham Stimulation
Arm Description
Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Outcomes
Primary Outcome Measures
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.
Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment
Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06028477
Brief Title
Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Official Title
Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 29, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.
Detailed Description
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Active Comparator
Arm Description
Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Intervention Type
Device
Intervention Name(s)
Stanford Glove
Intervention Description
The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.
Primary Outcome Measure Information:
Title
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
Description
Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.
Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment
Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.
Time Frame
Baseline and month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18 or older
Diagnosed with idiopathic Parkinson's Disease
Fluent in English
Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.
Exclusion Criteria:
Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
Pregnancy, breast-feeding or wanting to become pregnant
Physical limitations unrelated to PD that would affect motor ratings
Has implantation of a medical device
Sensory abnormalities of the fingertips
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Yankulova
Phone
650-474-9547
Email
jessky@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ellyn Daly
Email
ellynd@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivek P Buch, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
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