Stanford University
Stanford, California, 94305, United States
Location contact
Peter Tass, MD, Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05545826
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
Peter Tass, MD, Ph.D
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with early stage Parkinson's disease
Time frame: Baseline, 6 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. Assessment will be performed while participants are off PD medication.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 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.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Patients will smell 16 pens filled with a specific odor. One point is given to a correctly identified smell. The score is range from 0 to 16 with lower scores indicating smell loss.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Thresholds are obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and have to discriminate one pen containing an odorous solution from two blanks filled with the solvent. Sixteen concentrations are created by stepwise diluting previous ones by 1:2. Starting with the lowest odor concentration, a staircase paradigm is used where two subsequent correct identifications of the odorous pen or one incorrect answer marked a so-called turning point, and results in a decrease or increase of concentration in the next triplet. The threshold score is the mean of the last four turning points in the staircase, with the final score ranging between 1 and 16 points, with lower scores indicating an increased smell threshold.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Smell discrimination is obtained in a three alternative forced choice paradigm where subjects are repeatedly presented with triplets of pens and in which 2 have the same odorant and 1 has a different smell. Subjects were asked to indicate the single pen with a different smell.
The score is the sum of correctly identified odors. The scores in this task ranged from 0 to 16 points, which lower scores indicating a decrease in smell discrimination
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Visual acuity is assessed via the Early Treatment for Diabetic Retinopathy Study chart. Participants will read letters from the chart at a distance of four meters. Each eye will be assessed separately, with one eye occluded, as well as both eyes together.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Visual contrast sensitivity is assessed via the Pelli-Robson chart. Participants will read letters from the chart at a distance of one meter. Each eye will be assessed separately, with one eye occluded, as well as both eyes together.
Contact information is provided by the study sponsor or research team.
Ellyn Daly
CONTACT
Jessica Yankulova
CONTACT
Stanford University
Other
Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07716553
Basal Ganglia Diseases, Brain Diseases
Ferrara, Italy
View Trial DetailsNCT06293118
Basal Ganglia Diseases, Brain Diseases
View Trial DetailsNCT04753320
Autonomic Nervous System Diseases, Basal Ganglia Diseases
Baltimore, Maryland, United States
View Trial DetailsNCT07187466
Basal Ganglia Diseases, Brain Diseases
Decatur, Georgia, United States
View Trial Details