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

NCT06559098 | Not Yet Recruiting FDA Device

• 1 other identifier: 71579
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinsons; vibrotactile stimulation; vibration; PD; 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.

  Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months

Secondary Outcomes (11)

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

  24 months

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

  24 months

• Freezing of Gait Questionnaire (FOG) change

  24 months

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

  24 months

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

  24 months

Study Arms (1)

Stimulation

EXPERIMENTAL

Patients who were previously enrolled in a vibrotactile study meant to reduce symptoms associated with Parkinson's disease will be enrolled in the study and will be asked to stimulate with the Stanford Coordinated Reset(CR) glove in sessions that last 2 hours. Sessions may be daily or a few times weekly depending on the needs of the patient.

Device: Vibrotactile coordinated reset (vCR)

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

Also known as: Stanford Coordinated Reset Glove

Stimulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Stanford University: lead

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

Central Study Contacts

Jessica K Yankulova

CONTACT

650-474-9547; jessky@stanford.edu

Ellyn Daly

CONTACT

ellynd@stanford.edu

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: Principal Investigator

Model Details: Patients who have previously received non invasive vibrotactile stimulation meant to reduce symptoms of Parkinson's disease will be enrolled and will be asked to stimulate with the Stanford Coordinated Reset (CR) glove

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 5, 2024

Record last verified: 2024-08