Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation

N/ANot Yet RecruitingNCT06559098

Stanford University5 enrolled

Overview

The purpose of this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Vibrotactile coordinated reset (vCR)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any adult age 18 and older * Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4 * Fluent in English * If patient is on medication that affects brain function or alters Electroencephalography (EEG) activity, the patient must feel comfortable going off this medication prior to EEG recording * Appropriate social support if required during an off state. * 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. * Feels comfortable going off Parkinson's Disease(PD) related medication during in person study visits * Lives in the United States * Having previously been enrolled in a vCR pilot study Exclusion Criteria: * Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies * Any current drug or alcohol abuse. * 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 * Craniotomy * Brain surgery * Patient is unable to communicate properly with staff (i.e., severe speech problems) * Excessive drooling * A type of hairstyle that would impede the use of an EEG cap * Sensory abnormalities of the fingertips * Patient is taking a medication that may cause significant withdrawal effects. * Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors

Outcomes

Primary Outcomes

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication

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.

Time frame: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months

Secondary Outcomes

Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months

LEDD is calculated as a daily sum of levodopa in each Parkinson's medication

Time frame: 24 months

Parkinson's disease quality of life questionnaire-39 (PDQ-39)

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.

Time frame: 24 months

Freezing of Gait Questionnaire (FOG) change

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.

Time frame: 24 months

Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change

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.

Central Contacts

Jessica K Yankulova

CONTACT

650-474-9547 jessky@stanford.edu

Ellyn Daly

CONTACT

ellynd@stanford.edu

Data from ClinicalTrials.gov

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