Back to resultsVibrotactile Coordinated Reset for the Treatment of Advanced 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 focused on measuring Non-invasive
Eligibility Criteria
Inclusion Criteria:
- Age at the time of enrollment: 35 - 90 years
- 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 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.
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
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, 6 months, 12 months, 18 months and 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
Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months
LEDD is calculated as a daily sum of levodopa in each Parkinson's medication
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline, 6 months, 12 months, 18 months and 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 baseline, 6 months, 12 months, 18 months and 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.
Vibratory temporal discrimination task (VTDT) change from baseline, 6 months, 12 months, 18 months and 24 months.
The vibratory temporal discrimination task (VTDT) consists of two vibratory bursts, with one burst delivered to the index finger and one burst to the middle finger. This procedure will be performed on the right and left hand separately. The patient is instructed to judge if he/she felt a delay between the two vibratory bursts. The inner stimulus interval (ISI) is RECORDED when the participant indicates that they can feel a difference in time between the two vibrations. The ISI can range from 10ms-110 ms
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline, 6 months, 12 months, 18 months and 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, 6 months, 12 months, 18 months and 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, 6 months, 12 months, 18 months and 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.
Communicative Participation Item Bank (CPIB; Short Form) change from baseline, 6 months, 12 months, 18 months and 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.
Voice Handicap Index (VHI-10) change from baseline, 6 months, 12 months, 18 months and 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 EEG beta band power change from baseline, 6 months, 12 months, 18 months and 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) change from baseline, 6 months, 12 months, 18 months and 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.
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline, 6 months, 12 months, 18 months and 24 months.
The PDCRS is a cognitive test designed to designed to cover the full spectrum of cognitive defects associated with Parkinson's Disease. The total test score ranges from 0 - 134, with higher scores indicating less cognitive impairment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05504902
Brief Title
Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
Official Title
Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 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
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 advance 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
Keywords
Non-invasive
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 Advanced 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, 6 months, 12 months, 18 months and 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
Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months
Description
LEDD is calculated as a daily sum of levodopa in each Parkinson's medication
Time Frame
24 months
Title
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline, 6 months, 12 months, 18 months and 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 baseline, 6 months, 12 months, 18 months and 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
Vibratory temporal discrimination task (VTDT) change from baseline, 6 months, 12 months, 18 months and 24 months.
Description
The vibratory temporal discrimination task (VTDT) consists of two vibratory bursts, with one burst delivered to the index finger and one burst to the middle finger. This procedure will be performed on the right and left hand separately. The patient is instructed to judge if he/she felt a delay between the two vibratory bursts. The inner stimulus interval (ISI) is RECORDED when the participant indicates that they can feel a difference in time between the two vibrations. The ISI can range from 10ms-110 ms
Time Frame
24 months
Title
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline, 6 months, 12 months, 18 months and 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, 6 months, 12 months, 18 months and 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, 6 months, 12 months, 18 months and 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
Communicative Participation Item Bank (CPIB; Short Form) change from baseline, 6 months, 12 months, 18 months and 24 months.
Description
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.
Time Frame
24 months
Title
Voice Handicap Index (VHI-10) change from baseline, 6 months, 12 months, 18 months and 24 months.
Description
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.
Time Frame
24 months
Title
Spontaneous EEG beta band power change from baseline, 6 months, 12 months, 18 months and 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
Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline, 6 months, 12 months, 18 months and 24 months.
Description
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.
Time Frame
24 months
Title
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline, 6 months, 12 months, 18 months and 24 months.
Description
The PDCRS is a cognitive test designed to designed to cover the full spectrum of cognitive defects associated with Parkinson's Disease. The total test score ranges from 0 - 134, with higher scores indicating less cognitive impairment.
Time Frame
24 months
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 stages 2 to 4
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.
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
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
94303
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
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