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

NCT ID: NCT05504902

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2026-11-01

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.

Detailed Description

This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.

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

Intervention Type: 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

Interventions

Vibrotactile coordinated reset

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age at the time of enrollment: 18 years of age or older

2. Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4

3. Fluent in English

4. 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

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. Feels comfortable going off PD related medication during in person study visits.

8. 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. Physical limitations unrelated to PD that would affect motor ratings

6. Craniotomy

7. Brain surgery

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

9. Excessive drooling

10. A type of hair style that would impede the use of an EEG cap

11. Sensory abnormalities of the fingertips

12. Patient is taking a medication that may cause significant withdrawal effects

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

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vivek P. Buch

Protocol Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

66691

Identifier Type: -

Identifier Source: org_study_id