Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease

N/AEnrolling By InvitationNCT05504902

Stanford University35 enrolled

Overview

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR 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.

This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Vibrotactile coordinated resetDEVICE

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Advanced stage Parkinson's disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age at the time of enrollment: 18 years of age or older 2. Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4 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 12. Patient is taking a medication that may cause significant withdrawal effects

Locations (1)

Stanford University

Stanford, California, United States

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. This assessment is performed while participants are off Parkinson's-related medication.

Time frame: Baseline, 6 months, 12 months, 18 months, 24 months

Secondary Outcomes

Levodopa equivalent daily dose (LEDD)

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

Time frame: Baseline, 24 months

Parkinsons 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: Baseline, 6 months, 12 months, 18 months, 24 months

Freezing of Gait Questionnaire (FOG)

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: Baseline, 6 months, 12 months, 18 months, 24 months

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.