Parkinson DiseaseNCT05558189
Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
A study testing Vibrotactile Coordinated Reset (vCR) in people with Parkinson Disease, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 92 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Vibrotactile Coordinated Reset (vCR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2025to 21 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at the time of enrollment: 35 - 92 years
- Diagnosis of idiopathic Parkinson's disease
- Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
- Fluent in English
- 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.
- Lives in the United States
Who cannot join
- 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
- Patient is unable to communicate properly with staff (i.e., severe speech problems)
- Excessive drooling
Show all 9Show fewer
- Sensory abnormalities of the fingertips
- Deep Brain Stimulation treatment
- PD symptoms so severe and that the patient is bed-bound
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Vibrotactile Coordinated Reset (vCR)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile Coordinated Reset (vCR)Device
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants who have refractory Parkinson's disease post surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Coordinated Reset (vCR) | Experimental | 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. Receives: Device: Vibrotactile Coordinated Reset (vCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (11)
Levodopa equivalent daily dose (LEDD) change from baseline to 24 months
LEDD is calculated as a daily sum of levodopa in each Parkinson's medication
Measured: 24 months
Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 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.
Measured: 24 months
Voice Handicap Index (VHI-10) change from baseline to 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.
Measured: 24 months
Freezing of gait questionnaire (FOG) change from baseline to 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.
Measured: 24 months
Vibratory temporal discrimination task (VTDT) change from baseline to 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
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 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.
Measured: 24 months
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start20 Aug 2025 (estimated)
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Tass, MD, PhD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558189
- Sponsor's protocol ID
- 67601
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT05558189
- Acronym / sponsor ID
- 67601
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Coordinated Reset (vCR) | Experimental | Device: Vibrotactile Coordinated Reset (vCR)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. |
Who may qualify
- Ages
- 35 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age at the time of enrollment: 35 - 92 years
- Diagnosis of idiopathic Parkinson's disease
- Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
- Fluent in English
- Appropriate social support if required during an off state.
Key exclusion criteria (9 listed)
- 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
- Patient is unable to communicate properly with staff (i.e., severe speech problems)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile Coordinated Reset (vCR)The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants who have refractory Parkinson's disease post surgical treatment | Device | Vibrotactile Coordinated Reset (vCR) |
Primary outcome
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.
Time frame: 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.
11 secondary outcomes
Levodopa equivalent daily dose (LEDD) change from baseline to 24 months
Time frame: 24 months
Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.
Time frame: 24 months
Voice Handicap Index (VHI-10) change from baseline to 24 months
Time frame: 24 months
Freezing of gait questionnaire (FOG) change from baseline to 24 months
Time frame: 24 months
Vibratory temporal discrimination task (VTDT) change from baseline to 24 months.
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.
Time frame: 24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months.
Time frame: 24 months
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months.
Time frame: 24 months
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Coordinated Reset (vCR) in people with Parkinson Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica K Yankulova (650-474-9547, jessky@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.