Parkinson's DiseaseNCT05830110
Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
A study testing Active Vibrotactile Coordinated Reset in people with Parkinson's Disease, run by Synergic Medical Technologies, Inc. at 1 site in United States.
Trial summary
The purpose of the present research is to examine the effectiveness of a non-invasive, vibrotactile stimulation protocol, known as coordinated reset (CR), for the alleviation of motor symptoms in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Active Vibrotactile Coordinated Reset
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Jun 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages 45 and 90
- diagnosis of bilateral, moderate stage idiopathic PD
- qualify for EEG procedures
Who cannot join
- on dopamine agonist medications and exhibiting compulsive behaviors
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present research is to examine the effectiveness of a non-invasive, vibrotactile stimulation protocol, known as coordinated reset (CR), for the alleviation of motor symptoms in patients with Parkinson's disease (PD). PD patients exhibit rigidity, slowness (bradykinesia) and poverty (akinesia) of movement as well as other symptoms. Treatment for PD is either pharmacological (first line) or invasive deep brain stimulation. The non-invasive, vibrotactile stimulation approach uses a novel stimulation pattern to disrupt the pathophysiological mechanism that is responsible for PD symptoms and thus restore motor function.
Read the detailed description
Up to thirty adults with bilateral, moderate stage idiopathic PD will be enrolled in this longitudinal study. Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals. This longitudinal protocol will be open-ended to enable continued treatment to those interested / motivated.
Study treatment will consist of daily, four-hour vibrotactile Coordinated Reset (vCR) stimulation sessions on a continual basis. All daily vCR stimulation sessions will occur at the participant's home (ON-medication) and can be broken up into two, two-hour blocks (with no more than 12 hours between stimulation blocks) to be less cumbersome and better integrate into the participant's daily life. Daily home-based treatment will be unsupervised, though timely support is guaranteed by Synergic Medical Technologies (SMT) support staff when needed (e.g., when usability or IT issues arise). Daily stimulation / device usage will be automatically logged by the device and continuously monitored by SMT staff, meanwhile participants will keep a med diary so we can monitor their med usage (and how it relates to extended exposure) over time. Participants will be able to transition to an as-needed basis with treatment after four months and once they are familiar with the treatment and their body's response to it, to better alleviate PD symptoms.
- Conditions
- Parkinson's Disease
- Being tested
- Active Vibrotactile Coordinated Reset, Sham vibrotactile coordinated reset
- Keywords
- vibrotactile
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Vibrotactile Coordinated ResetDevice
Gloves providing vibrotactile coordinated reset stimulation
Sham vibrotactile coordinated resetDevice
Gloves providing sham vibrotactile coordinated reset stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active vibrotactile coordinated reset | Active comparator | mechanical vibrotactile stimulation to the fingers in a defined pattern Receives: Device: Active Vibrotactile Coordinated Reset |
| Sham vibrotactile coordinated reset | Sham comparator | mechanical vibrotactile stimulation to the fingers in a defined pattern Receives: Device: Sham vibrotactile coordinated reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)
Change in MDS-UPDRS score using Part 3 of the scale.
Measured: baseline, 2 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Mar 2023
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergic Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phan Luu, PhD, Principal investigator, Synergic Medical Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830110
- Sponsor's protocol ID
- VCR-Longitudinal
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05830110
- Acronym / sponsor ID
- VCR-Longitudinal
- Conditions
- Parkinson's Disease
- Keywords
- vibrotactile
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Synergic Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Apr 2023 (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 the present research is to examine the effectiveness of a non-invasive, vibrotactile stimulation protocol, known as coordinated reset (CR), for the alleviation of motor symptoms in patients with Parkinson's disease (PD). PD patients exhibit rigidity, slowness (bradykinesia) and poverty (akinesia) of movement as well as other symptoms. Treatment for PD is either pharmacological (first line) or invasive deep brain stimulation. The non-invasive, vibrotactile stimulation approach uses a novel stimulation pattern to disrupt the pathophysiological mechanism that is responsible for PD symptoms and thus restore motor function.
Detailed description
Up to thirty adults with bilateral, moderate stage idiopathic PD will be enrolled in this longitudinal study. Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals. This longitudinal protocol will be open-ended to enable continued treatment to those interested / motivated.
Study treatment will consist of daily, four-hour vibrotactile Coordinated Reset (vCR) stimulation sessions on a continual basis. All daily vCR stimulation sessions will occur at the participant's home (ON-medication) and can be broken up into two, two-hour blocks (with no more than 12 hours between stimulation blocks) to be less cumbersome and better integrate into the participant's daily life. Daily home-based treatment will be unsupervised, though timely support is guaranteed by Synergic Medical Technologies (SMT) support staff when needed (e.g., when usability or IT issues arise). Daily stimulation / device usage will be automatically logged by the device and continuously monitored by SMT staff, meanwhile participants will keep a med diary so we can monitor their med usage (and how it relates to extended exposure) over time. Participants will be able to transition to an as-needed basis with treatment after four months and once they are familiar with the treatment and their body's response to it, to better alleviate PD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals.
| Arm | Type | Receives |
|---|---|---|
| Active vibrotactile coordinated reset | Active comparator | Device: Active Vibrotactile Coordinated Resetmechanical vibrotactile stimulation to the fingers in a defined pattern |
| Sham vibrotactile coordinated reset | Sham comparator | Device: Sham vibrotactile coordinated resetmechanical vibrotactile stimulation to the fingers in a defined pattern |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between the ages 45 and 90
- diagnosis of bilateral, moderate stage idiopathic PD
- qualify for EEG procedures
Key exclusion criteria (1 listed)
- on dopamine agonist medications and exhibiting compulsive behaviors
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 |
|---|---|---|
| Active Vibrotactile Coordinated ResetGloves providing vibrotactile coordinated reset stimulation | Device | Active vibrotactile coordinated reset |
| Sham vibrotactile coordinated resetGloves providing sham vibrotactile coordinated reset stimulation | Device | Sham vibrotactile coordinated reset |
Primary outcome
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)
Time frame: baseline, 2 months, 4 months
Change in MDS-UPDRS score using Part 3 of the scale.
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 24 Apr 2026.
- 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. This study is not recruiting at the moment.
Phan Luu, PhD principal investigator
Synergic Medical Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Vibrotactile Coordinated Reset in people with Parkinson's Disease, run by Synergic Medical Technologies, Inc. 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS) (time frame: baseline, 2 months, 4 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 24 Apr 2026.