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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Vibrotactile coordinated reset

Detailed Description

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
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94303
      • 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: 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

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 Advanced 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) 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.	Baseline, 6 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 months, 12 months, 18 months, 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Spontaneous EEG beta band power	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Levodopa equivalent daily dose (LEDD)	LEDD is calculated as a daily sum of levodopa in each Parkinson's medication	Baseline, 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.	Baseline, 6 months, 12 months, 18 months, 24 months
Communicative Participation Item Bank (CPIB; Short Form)	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Voice Handicap Index (VHI-10)	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS)	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.	Baseline, 6 months, 12 months, 18 months, 24 months
Vibratory threshold	Participants will be assessed for their perceptive threshold of vibration, or the lowest vibration amplitude perceived. This is determined by adjusting the amplitude of the experimental device.	Baseline, 6 months, 12 months, 18 months, 24 months
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) on 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 on Parkinson's-related medication.	Baseline, 6 months, 12 months, 18 months, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Digitography Repetitive Alternating Finger Task (QDG-RAFT)	The QDG-RAFT requires participants to place their index and middle finger on adjacent keys of a digitography device. They are instructed to press and release each key in an alternating pattern, as fast and regularly as possible for thirty seconds, starting and stopping only when an auditory cue is heard. This is an exploratory measure.	Baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Non-invasive
• 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: 66691

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes