Parkinson DiseaseNCT05881460
Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease 2
A study testing Active vibrotactile coordinated reset in people with Parkinson Disease, run by Synergic Medical Technologies, Inc. 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 motor function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson 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
- 12 Jul 2023to 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 45-85
- Diagnosis of idiopathic Parkinson's disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following: rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar, or proprioceptive conditions
- Bilateral, moderate-stage impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state
- Able to walk and stand unassisted
- Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)
- Responsive to levodopa (self-reported)
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- Willing to keep exercise and medication regimen as stable as possible for the duration of the study
- Able to provide informed consent
- Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology
- Participants must speak English and can communicate with staff
- Patients live close to or in the area of where the clinic is located and are able to travel to the clinic for all screening and assessment appointments.
Who cannot join
- Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)
- BDI score > 28, indicating severe depression that precludes ability to adhere to protocol. Any subject with such a score will be referred to a Primary Care Physician (PCP) or physician for further evaluation and management of depression. Individuals with a BDI score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
- Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.
- Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
- Physical limitations unrelated to Parkinson's disease
- Recent change or addition of psychoactive medications for non-parkinsonian treatments
- Any kind of brain surgery or neurostimulators
- Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science Institution
Portland, Oregon, 97239
About this study
Official title: Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. vCR can be used in conjunction with medication and is expected to delay the need to increase dopamine medication. It also provides a more flexible alternative to deep brain stimulation (DBS) in that the vCR therapy can be easily stopped or modified to better suit the patients' needs.
Read the detailed description
This vCR study will include a crossover design, where participants are their own control and receive both active stimulation and sham, aiding in understanding true treatment effects from vCR.
Current treatments for PD include medications, surgical measures, or a combination of both. However, long term use of medications can result in intolerable side effects, especially at higher doses. Although DBS is FDA approved and an established method to manage symptoms of PD, it is an invasive and expensive procedure and may not improve all symptoms of PD. The team at Synergic Medical Technologies, Inc. developed a non-invasive method of applying vibrotactile stimulation delivered through the fingertips that has the potential of theoretically disrupting abnormal synchrony in the brain and thus alleviate severity in motor symptoms in people with PD.
The purpose of this study is to test the use of vibrotactile stimulation on 30 participants with PD and vCRs effects on motor ability using the VT Touch.
- Conditions
- Parkinson Disease
- Being tested
- Active vibrotactile coordinated reset, Sham vibrotactile coordinated reset
- 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
Also called VT Touch 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.
Sham vibrotactile coordinated resetDevice
Also called VT Touch glove
Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.
| Study group | Role | What they receive |
|---|---|---|
| Active vibrotactile coordinated reset | Active comparator | Participants will receive active Vibrotactile Coordinated Reset stimulation. Receives: Device: Active vibrotactile coordinated reset |
| Sham vibrotactile coordinated reset | Sham comparator | Participants will receive inactive Vibrotactile Coordinated Reset stimulation. Receives: Device: Sham vibrotactile coordinated reset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Difference in MDS-UPDRS Part 3 from baseline to 2 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse
Measured: baseline, 2 months, 3 months, 5 months
Secondary outcomes (3)
Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab
Difference in APDM gait speed from baseline to 2 months between active and sham
Measured: baseline, 2 months, 3 months, 5 months
Quality of life improvements
Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)
Measured: baseline, 2 months, 3 months, 5 months
Change in freezing severity index
Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters
Measured: baseline, 2 months, 3 months, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start12 Jul 2023
- Primary completionSep 2026 (estimated)
- Study completionNov 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.
- 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
- This study is a double-blinded, crossover trial, where participants are their own control and receive both active stimulation and sham.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergic Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Kraakivk, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881460
- Sponsor's protocol ID
- 25412
- Status last verified
- Apr 2026
- First submitted
- 19 May 2023
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05881460
- Acronym / sponsor ID
- 25412
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Synergic Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 May 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 our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. vCR can be used in conjunction with medication and is expected to delay the need to increase dopamine medication. It also provides a more flexible alternative to deep brain stimulation (DBS) in that the vCR therapy can be easily stopped or modified to better suit the patients' needs.
Detailed description
This vCR study will include a crossover design, where participants are their own control and receive both active stimulation and sham, aiding in understanding true treatment effects from vCR.
Current treatments for PD include medications, surgical measures, or a combination of both. However, long term use of medications can result in intolerable side effects, especially at higher doses. Although DBS is FDA approved and an established method to manage symptoms of PD, it is an invasive and expensive procedure and may not improve all symptoms of PD. The team at Synergic Medical Technologies, Inc. developed a non-invasive method of applying vibrotactile stimulation delivered through the fingertips that has the potential of theoretically disrupting abnormal synchrony in the brain and thus alleviate severity in motor symptoms in people with PD.
The purpose of this study is to test the use of vibrotactile stimulation on 30 participants with PD and vCRs effects on motor ability using the VT Touch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a double-blinded, crossover trial, where participants are their own control and receive both active stimulation and sham.
| Arm | Type | Receives |
|---|---|---|
| Active vibrotactile coordinated reset | Active comparator | Device: Active vibrotactile coordinated resetParticipants will receive active Vibrotactile Coordinated Reset stimulation. |
| Sham vibrotactile coordinated reset | Sham comparator | Device: Sham vibrotactile coordinated resetParticipants will receive inactive Vibrotactile Coordinated Reset stimulation. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Between the ages of 45-85
- Diagnosis of idiopathic Parkinson's disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following: rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar, or proprioceptive conditions
- Bilateral, moderate-stage impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state
- Able to walk and stand unassisted
- Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)
Key exclusion criteria (8 listed)
- Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)
- BDI score > 28, indicating severe depression that precludes ability to adhere to protocol. Any subject with such a score will be referred to a Primary Care Physician (PCP) or physician for further evaluation and management of depression. Individuals with a BDI score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
- Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.
- Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
- Physical limitations unrelated to Parkinson's disease
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 resetAlso: VT Touch 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 | Active vibrotactile coordinated reset |
| Sham vibrotactile coordinated resetAlso: VT Touch gloveVibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR. | Device | Sham vibrotactile coordinated reset |
Primary outcome
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time frame: baseline, 2 months, 3 months, 5 months
Difference in MDS-UPDRS Part 3 from baseline to 2 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse
3 secondary outcomes
Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab
Time frame: baseline, 2 months, 3 months, 5 months
Quality of life improvements
Time frame: baseline, 2 months, 3 months, 5 months
Change in freezing severity index
Time frame: baseline, 2 months, 3 months, 5 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 24 Apr 2026.
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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.
Jeff Kraakivk, MD principal investigator
Oregon Health and Science University
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 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 11 inclusion and 8 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?
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (time frame: baseline, 2 months, 3 months, 5 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.