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

NCT ID: NCT05558189

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-11-21

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Vibrotactile Coordinated Reset (vCR)

Intervention Type: 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

Interventions

Vibrotactile Coordinated Reset (vCR)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age at the time of enrollment: 35 - 92 years

2. Diagnosis of idiopathic Parkinson's disease

3. Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation

4. Fluent in English

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. 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. Patient is unable to communicate properly with staff (i.e., severe speech problems)

6. Excessive drooling

7. Sensory abnormalities of the fingertips

8. Deep Brain Stimulation treatment

9. PD symptoms so severe and that the patient is bed-bound

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 92 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Peter Tass, MD, PhD

Protocol Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Jessica K Yankulova

Role: CONTACT

jessky@stanford.edu

650-474-9547

Other Identifiers

67601

Identifier Type: -

Identifier Source: org_study_id