Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease

Synergic Medical Technologies, Inc.36 enrolled

Overview

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain 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. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.

Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease

Interventions

Active 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.

Sham Vibrotactile Coordinated Reset (vCR)DEVICE

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

1. Between the ages of 45-85 2. Diagnosis of idiopathic Parkinson's disease 3. Bilateral impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state 4. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor improvement greater than or equal to 30% when on medication compared to when off medication. 5. Participants must be on stable dose of dopaminergic medication for 1 month prior to baseline visit. 6. Able to provide informed consent. 7. Appropriate social support if required during an off state. 8. 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. 9. Participants must speak English and can communicate with staff without the need of an interpreter. 10. 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 recordings Exclusion Criteria 1. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism. 2. Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc…). 3. Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies. 4. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days. 5. Physical limitations unrelated to Parkinson's disease. 6. Speech problems or excessive drooling so severe patient cannot communicate properly to staff. 7. Presences of dopamine dysregulation syndrome. 8. On dopamine agonist(s) and exhibits compulsive behaviors. 9. Current delirium 10. Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study. 11. History of epilepsy or traumatic brain injury. 12. Brain surgery (i.e. DBS implantation) or craniotomy. 13. Neurostimulator. 14. A type of hairstyle that would impede the use of a EEG cap 15. Severe sensory abnormalities of the fingertips such as vibratory urticaria. 16. Current or ongoing hallucinations, delusions. 17. The PI and study's neurologist deems the patient ineligible. 18. Patient has a functional movement disorder that prevents accurate Parkinson's disease evaluations

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3

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 evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months

Time frame: 14months

Secondary Outcomes

Spontaneous electroencephalography (EEG)

Spontaneous EEG is recorded at baseline, 3, 6 and 7 months. 3 types of recordings will occur per visit:5 minute Baseline, 16 minute during vibrotactile therapy (sham or active vCR depending on the participant group) and post vibrotactile therapy. Power spectral density (PSD) will be calculated from source constructed EEG activity for each frequency band of interest (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; and Gamma: 31-50 Hz) using the Welch method with a 2-s window overlapping by 50%. Relative power (RP) is calculated by taking the sum of each frequency band and dividing it by the total power across the spectrum (2-50 Hz).

Time frame: 7 months

Sensorimotor task EEG

Sensorimotor activity during the EEG will be recorded at baseline, 3, 6 and 7 months. Patients receive a single vibratory stimulus to a random finger (excluding the thumb) on their left or right hand and are instructed with their non-stimulated hand to push the response button as fast as possible when they feel the vibratory burst. Each finger receives an equal number of vibratory pulses (50 per finger, equaling 200 trials per hand) in a randomized order. Cortically, we expect to look at motor evoked potentials in response to cued vibration by means of their amplitude (micro-volts) and latency (time in milliseconds) and their changes throughout the course of treatment. Reaction time (in milliseconds) will also be documented.

Time frame: 7 months

Data from ClinicalTrials.gov

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