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

Stanford University

Status: Invitation-only

Conditions: Parkinson Disease

Treatments: Device: Vibrotactile coordinated reset

Study type: Interventional

Funder types: Other

Identifiers

NCT05504902

66691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 92 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 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