Parkinson Disease
Conditions
Keywords
Parkinsons, vibrotactile stimulation, vibration, PD, Non-invasive
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.
Interventions
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
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication | Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months | This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's disease quality of life questionnaire-39 (PDQ-39) | 24 months | The PD Quality of Life Questionnaire-39 (PDQ-39) is a self-report questionnaire that examines health related difficulties specific to PD in eight quality of life categories within the last month. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100, with higher % indicating more health problems. |
| Freezing of Gait Questionnaire (FOG) change | 24 months | The Freezing of Gait questionnaire (FOG) assesses severity unrelated to falls in patients with Parkinson's Disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects (e.g., turning). The FOG is comprised of 6 questions measured on a 0 to 4 scale (where 0 is normal and 4 represents severe abnormalities). The scores are summed together with 0 representing the best possible score and 24 representing the worst possible score. |
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change | 24 months | The MDS-UPDRS part 1 focuses on non-motor symptoms, such as dementia, depression, and psychosis. The total summed score ranges from 0-52 with higher scores indicating increased non-motor impairment. |
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 | 24 months | The MDS-UPDRS part 2 focuses on the patient's ability to perform daily motor activities including dressing, grooming, and using utensils. The total summed score ranges from 0-52 with higher scores indicating increased daily motor impairment |
| Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change | 24 months | The MDS-UPDRS 4 focuses on Measures the complications of treatment, e.g. dyskinesias and motor fluctuations. The total summed score ranges from 0-24 with higher scores indicating increased motor complications. |
| Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months | 24 months | LEDD is calculated as a daily sum of levodopa in each Parkinson's medication |
| Voice Handicap Index (VHI-10) | 24 months | This questionnaire can be filled out by patients and assesses the impact that voice problems and limitations have on the individual's overall daily function. Questionnaire is scored from 0 to 40, with a higher score indicating increased speech difficulties. |
| Spontaneous Electroencephalography beta band power change | 24 months | Patients will be recorded while receiving vibrotactile stimulation. The Beta Band (13-30Hz) power spectral density (PSD) will be of interest. The units of the power spectral density are micro-Volts-squared per Hz. Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement. |
| Parkinson's disease cognitive functional rating scale (PD-CFRS) | 24 months | The PD-CFRS capture subjective daily functional cognitive decline among patients with Parkinson's disease over the past 2 weeks. The scale ranges from 0 to 24, with higher scores indicative of cognitive decline. |
| Device calibration | 24 months | Participants will be assessed for their perceptive threshold of vibration, or the lowest vibration amplitude perceived. This is determined by adjusting the amplitude of the experimental device. |
| Communicative Participation Item Bank (CPIB; Short Form) | 24 months | The CPIB is a questionnaire that measures speech complications. The questionnaire is scored from 0 to 30, with a higher score indicating increased speech difficulties. |
Contacts
Primary ContactJessica K Yankulova
Backup ContactEllyn Daly
Outcome results
None listed