Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
NCT ID: NCT06028477
Last Updated: 2024-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2025-01-10
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active stimulation
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
Stanford Glove
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.
Sham Stimulation
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
Stanford Glove
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.
Interventions
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Stanford Glove
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
92 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Vivek P. Buch
Assistant Professor of Neurosurgery
Principal Investigators
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Vivek P Buch, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Other Identifiers
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71954
Identifier Type: -
Identifier Source: org_study_id
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