Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06028477
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 92 Years
Healthy Volunteers
Not accepted

Interventions

  • Stanford Glove — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 10, 2025
Status verified
Aug 2024
Primary completion
Dec 30, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Sham Comparator: 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

Primary Outcome Measure

Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score [ Time Frame: Baseline and month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

Find similar trials in Stanford, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Stanford University· Stanford, CA

Related Studies