NCT06028477

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
9mo left

Started Jan 2025

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2025Mar 2027

First Submitted

Initial submission to the registry

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 31, 2023

Last Update Submit

August 15, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and month 6

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

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

Device: Stanford Glove

Sham Stimulation

SHAM COMPARATOR

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

Device: Stanford Glove

Interventions

Stanford GloveDEVICE

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.

Active stimulationSham Stimulation

Eligibility Criteria

Age18 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Vivek P Buch, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Yankulova

CONTACT

650-474-9547jessky@stanford.edu

Ellyn Daly

CONTACT

ellynd@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 8, 2023

Study Start

January 10, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)