Clinical trial NCT06559098: Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
Official title: Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinsons
vibrotactile stimulation
vibration
PD
Non-invasive
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who have previously received non invasive vibrotactile stimulation meant to reduce symptoms of Parkinson's disease will be enrolled and will be asked to stimulate with the Stanford Coordinated Reset (CR) glove
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.


Eligibility criteria: Inclusion Criteria:

* Any adult age 18 and older
* Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
* Fluent in English
* If patient is on medication that affects brain function or alters Electroencephalography (EEG) activity, the patient must feel comfortable going off this medication prior to EEG recording
* Appropriate social support if required during an off state.
* 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.
* Feels comfortable going off Parkinson's Disease(PD) related medication during in person study visits
* Lives in the United States
* Having previously been enrolled in a vCR pilot study

Exclusion Criteria:

* Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
* Any current drug or alcohol abuse.
* 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.
* Pregnancy, breast-feeding or wanting to become pregnant
* Physical limitations unrelated to PD that would affect motor ratings
* Craniotomy
* Brain surgery
* Patient is unable to communicate properly with staff (i.e., severe speech problems)
* Excessive drooling
* A type of hairstyle that would impede the use of an EEG cap
* Sensory abnormalities of the fingertips
* Patient is taking a medication that may cause significant withdrawal effects.
* Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors

Primary outcomes:
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
timeFrame: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months
Secondary outcomes:
measure: Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months
timeFrame: 24 months
measure: Parkinson's disease quality of life questionnaire-39 (PDQ-39)
timeFrame: 24 months
measure: Freezing of Gait Questionnaire (FOG) change
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change
timeFrame: 24 months
measure: Communicative Participation Item Bank (CPIB; Short Form)
timeFrame: 24 months
measure: Voice Handicap Index (VHI-10)
timeFrame: 24 months
measure: Spontaneous Electroencephalography beta band power change
timeFrame: 24 months
measure: Parkinson's disease cognitive functional rating scale (PD-CFRS)
timeFrame: 24 months
measure: Device calibration
timeFrame: 24 months
Other outcomes:
Locations:
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