Clinical trial NCT05504902: Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
Official title: Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: Non-invasive
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 35
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 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.

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

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: Levodopa equivalent daily dose (LEDD)
timeFrame: Baseline, 24 months
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: Communicative Participation Item Bank (CPIB; Short Form)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Voice Handicap Index (VHI-10)
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: Parkinson's disease cognitive functional rating scale (PD-CFRS)
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Vibratory threshold
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) on medication
timeFrame: Baseline, 6 months, 12 months, 18 months, 24 months
Other outcomes:
measure: Quantitative Digitography Repetitive Alternating Finger Task (QDG-RAFT)
timeFrame: Baseline, 1 week, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: