Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on refractory post-surgery PD. 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 (vCR)

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

Contacts and Locations

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

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

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. Diagnosis of idiopathic Parkinson's disease
3. Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
4. Fluent in English
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. 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. Patient is unable to communicate properly with staff (i.e., severe speech problems)
6. Excessive drooling
7. Sensory abnormalities of the fingertips
8. Deep Brain Stimulation treatment
9. PD symptoms so severe and that the patient is bed-bound

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 (vCR); The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants who have refractory Parkinson's disease post surgical treatment

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 24 months.	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
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
Levodopa equivalent daily dose (LEDD) change from baseline to 24 months	LEDD is calculated as a daily sum of levodopa in each Parkinson's medication	24 months
Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.	The CPIB is a questionnaire that measures speech complications. The questionnaire is scored from 0 to 30, with a higher score indicating increased speech difficulties.	24 months
Voice Handicap Index (VHI-10) change from baseline to 24 months	This questionnaire can be filled out by patients and assesses the impact that voice problems and limitations have on the individual's overall daily function. Questionnaire is scored from 0 to 40, with a higher score indicating increased speech difficulties.	24 months
Vibratory temporal discrimination task (VTDT) change from baseline to 24 months.	The vibratory temporal discrimination task (VTDT) consists of two vibratory bursts, with one burst delivered to the index finger and one burst to the middle finger. This procedure will be performed on the right and left hand separately. The patient is instructed to judge if he/she felt a delay between the two vibratory bursts. The inner stimulus interval (ISI) is RECORDED when the participant indicates that they can feel a difference in time between the two vibrations. The ISI can range from 10ms-110 ms	24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months.	The PD-CFRS capture subjective daily functional cognitive decline among patients with Parkinson's disease over the past 2 weeks. The scale ranges from 0 to 24, with higher scores indicative of cognitive decline.	24 months
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months.	The PDCRS is a cognitive test designed to designed to cover the full spectrum of cognitive defects associated with Parkinson's Disease. The total test score ranges from 0 - 134, with higher scores indicating less cognitive impairment.	24 months
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
Freezing of gait questionnaire (FOG) 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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): November 21, 2025
• Study Completion (Estimated): November 21, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 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: 67601

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