Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients

NCT05558189 | Not Yet Recruiting FDA Device

• 1 other identifier: 67601
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on refractory post-surgery PD. vCR will be administered with a device called the Stanford 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

Outcome Measures

Primary Outcomes (1)

• Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.

  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.

  24 months

Secondary Outcomes (11)

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

  24 months

• Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.

  24 months

• Voice Handicap Index (VHI-10) change from baseline to 24 months

  24 months

• Freezing of gait questionnaire (FOG) change from baseline to 24 months

  24 months

• Vibratory temporal discrimination task (VTDT) change from baseline to 24 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 (vCR)

Interventions

Vibrotactile Coordinated Reset (vCR) DEVICE

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants who have refractory Parkinson's disease post surgical treatment

Vibrotactile Coordinated Reset (vCR)

Eligibility Criteria

• Age: 35 Years - 92 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: 35 - 92 years
• Diagnosis of idiopathic Parkinson's disease
• Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
• Fluent in English
• 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.
• 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
• Patient is unable to communicate properly with staff (i.e., severe speech problems)
• Excessive drooling
• Sensory abnormalities of the fingertips
• Deep Brain Stimulation treatment
• PD symptoms so severe and that the patient is bed-bound

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, 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

Central Study Contacts

Jessica K Yankulova

CONTACT

650-474-9547; jessky@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: Protocol Director

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: August 20, 2025
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

US (1)