Back to resultsVCR: A Treatment for Early Stage Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrotactile coordinated reset
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Age at the time of enrollment: 35 - 90 years
- Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
- Fluent in English
- 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
- 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 PD related medication during in person study visits
- Lives in the United States
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 with the exception of burr holes.
- 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
- Nasal Disfunction unrelated to smell loss -
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vibrotactile Coordinated Reset (vCR)
Arm Description
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.
Outcomes
Primary Outcome Measures
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III change from baseline to 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 Outcome Measures
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 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 from change from baseline to 24 months.
The FOGQ assesses Freezing of Gait (FOG) 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 from baseline to 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 change from baseline to 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 from baseline to 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.
Spontaneous EEG beta band power change from baseline to 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.
Smell Identification change from baseline change from baseline to 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.
Smell threshold change from baseline to 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.
Smell discrimination change from baseline to 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
Full Information
NCT ID
NCT05545826
First Posted
September 12, 2022
Last Updated
December 5, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT05545826
Brief Title
VCR: A Treatment for Early Stage Parkinson's Disease
Official Title
Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
October 20, 2025 (Anticipated)
Study Completion Date
October 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 vibrotactile axon 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibrotactile Coordinated Reset (vCR)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vibrotactile coordinated reset
Intervention Description
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
Primary Outcome Measure Information:
Title
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III change from baseline to 24 months.
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months.
Description
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
24 months
Title
Freezing of gait questionnaire (FOG) change from change from baseline to 24 months.
Description
The FOGQ assesses Freezing of Gait (FOG) 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
24 months
Title
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.
Description
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
24 months
Title
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.
Description
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
24 months
Title
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.
Description
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
24 months
Title
Spontaneous EEG beta band power change from baseline to 24 months.
Description
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
24 months
Title
Smell Identification change from baseline change from baseline to 24 months.
Description
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
24 months
Title
Smell threshold change from baseline to 24 months.
Description
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
24 months
Title
Smell discrimination change from baseline to 24 months.
Description
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
24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at the time of enrollment: 35 - 90 years
Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
Fluent in English
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
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 PD related medication during in person study visits
Lives in the United States
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 with the exception of burr holes.
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
Nasal Disfunction unrelated to smell loss -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Yankulova
Phone
650-474-9547
Email
jessky@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Tass, MD, Ph.D
12. IPD Sharing Statement
Learn more about this trial
VCR: A Treatment for Early Stage Parkinson's Disease
We'll reach out to this number within 24 hrs