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

NCT ID: NCT06559098

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulation

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.

Group Type: EXPERIMENTAL

Vibrotactile coordinated reset (vCR)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Stanford Coordinated Reset Glove

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vivek P. Buch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jessica K Yankulova

Role: CONTACT

jessky@stanford.edu

650-474-9547

Ellyn Daly

Role: CONTACT

ellynd@stanford.edu

Other Identifiers

71579

Identifier Type: -

Identifier Source: org_study_id