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

Stanford University

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Vibrotactile Coordinated Reset (vCR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05558189

67601

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 35 to 92 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Vibrotactile Coordinated Reset (vCR)

Experimental group

Description:

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.

Treatment:

Device: Vibrotactile Coordinated Reset (vCR)