Clinical trial NCT05545826: Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease
Official title: Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms. 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.


Eligibility criteria: Inclusion Criteria:

1. Ages 18 and older
2. Idiopathic Parkinson's disease Hoehn and Yahr stage I
3. Fluent in English
4. Appropriate social support if required during an off state.
5. 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.
6. Feels comfortable going off PD related medication during in person study visits
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. 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. Nasal dysfunction unrelated to smell loss

Primary outcomes:
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
measure: Parkinsons disease quality of life questionnaire-39 (PDQ-39)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Freezing of gait questionnaire (FOG)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Spontaneous EEG beta band power
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Smell Identification
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Smell threshold
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Smell discrimination
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Visual acuity
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Visual contrast sensitivity
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: