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

NCT05504902 | Enrolling By Invitation FDA Device

• 1 other identifier: 66691
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Non-invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Levodopa equivalent daily dose (LEDD)

  Baseline, 24 months

• Parkinsons disease quality of life questionnaire-39 (PDQ-39)

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

• Freezing of Gait Questionnaire (FOG)

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

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

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

• Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2

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

Other Outcomes (1)

• Quantitative Digitography Repetitive Alternating Finger Task (QDG-RAFT)

  Baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months

Study Arms (1)

Vibrotactile Coordinated Reset (vCR)

EXPERIMENTAL

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

Interventions

Vibrotactile coordinated reset DEVICE

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

Vibrotactile Coordinated Reset (vCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: 18 years of age or 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 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 PD related medication during in person study visits.
• Lives in the United States

You may not qualify if:

• 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 hair style 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94303, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Director

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: August 30, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)