Parkinson Disease, IdiopathicNCT06583005
Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
A study testing Vibrotactile Coordinated Reset in people with Parkinson Disease, Idiopathic, run by Stanford University.
Trial summary
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Vibrotactile Coordinated Reset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at the time of enrollment: Adults 18 and older
- Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
- Fluent in English
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- Vibrotactile Coordinated Reset
- Keywords
- vibrotactile, vibrotactile coordinated reset, parkinsons disease
- 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 ResetDevice
The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | Participants will stimulate with the device, called the Stanford CR glove, on a daily or weekly basis depending on their progress through the study procedures. The device itself is a glove that is designed to deliver vibrations to the fingertips of each hand. Receives: Device: Vibrotactile Coordinated Reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS Part 3
The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 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, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start15 Feb 2025 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies 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
- 20 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
- NCT06583005
- Sponsor's protocol ID
- 75389
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
- ClinicalTrials.gov ID
- NCT06583005
- Acronym / sponsor ID
- 75389
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- vibrotactile, vibrotactile coordinated reset, parkinsons disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 3 Sep 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 clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Vibrotactile Coordinated ResetParticipants will stimulate with the device, called the Stanford CR glove, on a daily or weekly basis depending on their progress through the study procedures. The device itself is a glove that is designed to deliver vibrations to the fingertips of each hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at the time of enrollment: Adults 18 and older
- Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
- Fluent in English
- 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
Key exclusion criteria (6 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 ResetThe Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony. | Device | Stimulation |
Primary outcome
MDS-UPDRS Part 3
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 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.
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Coordinated Reset in people with Parkinson Disease, Idiopathic, 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 5 inclusion and 6 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 3 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 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?
MDS-UPDRS Part 3 (time frame: Baseline, 6 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 3 Sep 2024.