Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029686
Collaborator
(none)
20
1
25

Study Details

Study Description

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms of a more variable population. 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 two years.

Condition or Disease Intervention/Treatment Phase
  • Device: Stanford Glove
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stimulation

Patients will be asked to stimulate using a non invasive vibrotactile device.

Device: Stanford Glove
The vibrotactile device sends weak non-painful pattern type vibratory stimulus to the fingertips and is non-invasive. Some patient may experience dyskinesia which can me medicated with a decrease in Parkinson's medication

Outcome Measures

Primary Outcome Measures

  1. Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age at the time of enrollment: 35 - 92 years

  2. Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to

  3. Fluent in English

  4. 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.

  5. Feels comfortable going off PD related medication during in person study visits

  6. Lives in the United States

Exclusion Criteria:
  1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies

  2. Any current drug or alcohol abuse.

  3. 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.

  4. Pregnancy, breast-feeding or wanting to become pregnant

  5. Craniotomy

  6. Brain surgery

  7. Patient is unable to communicate properly with staff (i.e., severe speech problems)

  8. Excessive drooling

  9. Patient is taking a medication that may cause significant withdrawal effects

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Tass, MD, PhD, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT06029686
Other Study ID Numbers:
  • 71725
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023