CClinicalTrials.gg
Active, not recruitingNCT05881460Updated Apr 24, 2026

Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease 2

An interventional study of Active vibrotactile coordinated reset and Sham vibrotactile coordinated reset in Parkinson Disease, sponsored by Synergic Medical Technologies, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Synergic Medical Technologies, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Parkinson Disease

Browse trials for

03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Synergic Medical Technologies, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between the ages of 45-85
  2. 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
  3. Bilateral, moderate-stage impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state
  4. Able to walk and stand unassisted
  5. Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)
  6. Responsive to levodopa (self-reported)
  7. Willing to keep exercise and medication regimen as stable as possible for the duration of the study
  8. Able to provide informed consent
  9. Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology
  10. Participants must speak English and can communicate with staff
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.

  2. Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.
  3. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
  4. Physical limitations unrelated to Parkinson's disease
  5. Recent change or addition of psychoactive medications for non-parkinsonian treatments
  6. Any kind of brain surgery or neurostimulators
  7. Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Active vibrotactile coordinated reset

    Participants will receive active Vibrotactile Coordinated Reset stimulation.

    Device: Active vibrotactile coordinated reset

  • Sham comparator
    Sham vibrotactile coordinated reset

    Participants will receive inactive Vibrotactile Coordinated Reset stimulation.

    Device: Sham vibrotactile coordinated reset

Interventions

  • DeviceActive vibrotactile coordinated reset

    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.

    Also known as: VT Touch glove

  • DeviceSham vibrotactile coordinated reset

    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.

    Also known as: VT Touch glove

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline, 2 months, 3 months, 5 months

Secondary outcomes

  1. 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

    Time frame: baseline, 2 months, 3 months, 5 months

  2. Quality of life improvements

    Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)

    Time frame: baseline, 2 months, 3 months, 5 months

  3. Change in freezing severity index

    Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters

    Time frame: baseline, 2 months, 3 months, 5 months

07

Study locations

1 site
  • Oregon Health & Science Institution
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05881460
Lead sponsor
Synergic Medical Technologies, Inc.
Responsible party
Sponsor
First posted
May 31, 2023
Start date
Jul 12, 2023
Primary completion
Sep 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Jeff Kraakivk, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion