Clinical trial NCT05558189: Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
Official title: Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 92
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.
timeFrame: 24 months
Secondary outcomes:
measure: Levodopa equivalent daily dose (LEDD) change from baseline to 24 months
timeFrame: 24 months
measure: Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.
timeFrame: 24 months
measure: Voice Handicap Index (VHI-10) change from baseline to 24 months
timeFrame: 24 months
measure: Freezing of gait questionnaire (FOG) change from baseline to 24 months
timeFrame: 24 months
measure: Vibratory temporal discrimination task (VTDT) change from baseline to 24 months.
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.
timeFrame: 24 months
measure: Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.
timeFrame: 24 months
measure: Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months.
timeFrame: 24 months
measure: Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months.
timeFrame: 24 months
measure: Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References: