Parkinson DiseaseNCT06559098
Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
A study testing Vibrotactile coordinated reset (vCR) in people with Parkinson Disease, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 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
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Sep 2027
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
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
- Physical limitations unrelated to PD that would affect motor ratings
- Craniotomy
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ellyn Daly contact
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Vibrotactile coordinated reset (vCR)
- Keywords
- Parkinsons, vibrotactile stimulation, vibration, PD, Non-invasive
- 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
Also called Stanford Coordinated Reset Glove
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
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | Patients who were previously enrolled in a vibrotactile study meant to reduce symptoms associated with Parkinson's disease will be enrolled in the study and will be asked to stimulate with the Stanford Coordinated Reset(CR) glove in sessions that last 2 hours. Sessions may be daily or a few times weekly depending on the needs of the patient. 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) off medication
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: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 24 Months
Secondary outcomes (11)
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
Measured: 24 months
Parkinson's disease quality of life questionnaire-39 (PDQ-39)
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
Freezing of Gait Questionnaire (FOG) change
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
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change
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
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
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
Communicative Participation Item Bank (CPIB; Short Form)
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)
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
Spontaneous Electroencephalography beta band power change
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.
Measured: 24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS)
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
Device calibration
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.
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 posted19 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (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
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivek P. Buch, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559098
- Sponsor's protocol ID
- 71579
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 5 Sep 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
- ClinicalTrials.gov ID
- NCT06559098
- Acronym / sponsor ID
- 71579
- Conditions
- Parkinson Disease
- Keywords
- Parkinsons, vibrotactile stimulation, vibration, PD, Non-invasive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Aug 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Vibrotactile coordinated reset (vCR)Patients who were previously enrolled in a vibrotactile study meant to reduce symptoms associated with Parkinson's disease will be enrolled in the study and will be asked to stimulate with the Stanford Coordinated Reset(CR) glove in sessions that last 2 hours. Sessions may be daily or a few times weekly depending on the needs of the patient. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 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
- Physical limitations unrelated to PD that would affect motor ratings
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)Also: Stanford Coordinated Reset GloveVibrotactile 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 | Device | Stimulation |
Primary outcome
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
Time frame: 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.
11 secondary outcomes
Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months
Time frame: 24 months
Parkinson's disease quality of life questionnaire-39 (PDQ-39)
Time frame: 24 months
Freezing of Gait Questionnaire (FOG) change
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2
Time frame: 24 months
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change
Time frame: 24 months
Communicative Participation Item Bank (CPIB; Short Form)
Time frame: 24 months
Voice Handicap Index (VHI-10)
Time frame: 24 months
Spontaneous Electroencephalography beta band power change
Time frame: 24 months
Parkinson's disease cognitive functional rating scale (PD-CFRS)
Time frame: 24 months
Device calibration
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 5 Sep 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.
Ellyn Daly contact
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.
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 9 inclusion and 13 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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) off medication (time frame: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 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 5 Sep 2024.