Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease

Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage 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 two years.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Vibrotactile coordinated reset

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Yankulova; Phone Number: 650-474-9547; Email: jessky@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Principal Investigator: Peter Tass, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age at the time of enrollment: 35 - 92 years
2. Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
3. Fluent in English
4. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
5. Appropriate social support if required during an off state.
6. 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.
7. Feels comfortable going off PD related medication during in person study visits
8. 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. Physical limitations unrelated to PD that would affect motor ratings
6. Craniotomy
7. Brain surgery
8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
9. Excessive drooling
10. A type of hair style that would impede the use of an EEG cap
11. Sensory abnormalities of the fingertips

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibrotactile Coordinated Reset (vCR); Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.	Device: Vibrotactile coordinated reset; The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with early stage Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 6 months, 6 months to 12 months, 12 months to 18 months and 18 months to 24 months while patients are off mediction.	This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months.	The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems.	24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.	The MDS-UPDRS part 1 focuses on non-motor symptoms, such as dementia, depression, and psychosis. The total summed score ranges from 0-52 with higher scores indicating increased non-motor impairment.	24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.	The MDS-UPDRS part 2 focuses on the patient's ability to perform daily motor activities including dressing, grooming, and using utensils. The total summed score ranges from 0-52 with higher scores indicating increased daily motor impairment.	24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.	The MDS-UPDRS 4 focuses on Measures the complications of treatment, e.g. dyskinesias and motor fluctuations. The total summed score ranges from 0-24 with higher scores indicating increased motor complications.	24 months
Spontaneous EEG beta band power change from baseline to 24 months.	Patients will be recorded while receiving vibrotactile stimulation. The Beta Band (13-30Hz) power spectral density (PSD) will be of interest. The units of the power spectral density are micro-Volts-squared per Hz. Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement.	24 months
Smell Identification change from baseline change from baseline to 24 months.	Patients will smell 16 pens filled with a specific odor. One point is given to a correctly identified smell. The score is range from 0 to 16 with lower scores indicating smell loss.	24 months
Smell threshold change from baseline to 24 months.	Thresholds are obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and have to discriminate one pen containing an odorous solution from two blanks filled with the solvent. Sixteen concentrations are created by stepwise diluting previous ones by 1:2. Starting with the lowest odor concentration, a staircase paradigm is used where two subsequent correct identifications of the odorous pen or one incorrect answer marked a so-called turning point, and results in a decrease or increase of concentration in the next triplet. The threshold score is the mean of the last four turning points in the staircase, with the final score ranging between 1 and 16 points, with lower scores indicating an increased smell threshold.	24 months
Freezing of gait questionnaire (FOG) change from change from baseline to 24 months.	The Freezing of Gait Questionnaire (FOG) assesses severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score.	24 months
Smell discrimination change from baseline to 24 months.	Smell discrimination is obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and in which 2 have the same odorant and 1 has a different smell. Subjects were asked to indicate the single pen with a different smell. The score is the sum of correctly identified odors. The scores in this task ranged from 0 to 16 points, which lower scores indicating a decrease in smell discrimination	24 months
Visual acuity change from baseline to 24 months.	Visual acuity is assessed via the Early Treatment for Diabetic Retinopathy Study chart. Participants will read letters from the chart at a distance of four meters. Each eye will be assessed separately, with one eye occluded, as well as both eyes together.	24 months
Visual contrast sensitivity change from baseline to 24 months.	Visual contrast sensitivity is assessed via the Pelli-Robson chart. Participants will read letters from the chart at a distance of one meter. Each eye will be assessed separately, with one eye occluded, as well as both eyes together.	24 months

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 67304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No