Vibrotactile Stimulation for Parkinson's Disease

Overseen By Jeff Kraakevik, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Synergic Medical Technologies, Inc.

Must be taking: PD medications

Must not be taking: Psychoactive medications

Disqualifiers: Severe depression, Other neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Vibrotactile Coordinated Reset (vCR) to improve movement in people with Parkinson's disease. The treatment uses a special device to deliver gentle vibrations, aiming to delay the need for more dopamine medication and provide a flexible alternative to deep brain stimulation. Participants will receive either the active treatment or a placebo (inactive treatment) to compare results. The trial seeks individuals diagnosed with Parkinson's who experience moderate movement challenges, such as tremors or stiffness, and are currently managing their condition with stable medication. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current Parkinson's medications. In fact, participants must be on a stable regimen of Parkinson's medication for at least 4 weeks before joining and should keep their medication regimen as stable as possible during the study.

What prior data suggests that the Vibrotactile Touch device is safe for Parkinson's disease patients?

Studies have shown that Vibrotactile Coordinated Reset (vCR) is safe and well-tolerated in people with Parkinson's disease. In one study with 44 participants, researchers used a wearable device that provides gentle vibrations, and no serious side effects were reported. Another study with eight patients found that both regular and varied vCR treatments were well-tolerated, with no side effects. These findings suggest that vCR may be a safe option for those seeking new ways to manage Parkinson's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrotactile Coordinated Reset for Parkinson's Disease because it offers a fresh approach compared to standard treatments like levodopa and dopamine agonists. Unlike these medications, which primarily aim to increase dopamine levels in the brain, this technique uses gentle vibrations to potentially reset abnormal brain activity patterns associated with Parkinson's. This non-invasive method could provide a new way to manage symptoms without the side effects often linked to traditional drug therapies.

What evidence suggests that the Vibrotactile Coordinated Reset device is effective for Parkinson's disease?

Research has shown that Vibrotactile Coordinated Reset (vCR) can improve movement in people with Parkinson's disease by reducing unusual brain activity. A previous study found that vCR disrupts these unusual patterns in the brain area controlling movement, leading to better motor skills. Clinical observations confirmed that movement abilities improved after using vCR. In this trial, participants will receive either the active Vibrotactile Coordinated Reset or a sham version. This non-invasive treatment does not involve surgery and can be easily adjusted or stopped, offering more flexibility than options like deep brain stimulation. ^{1 2 3 5 6}

Who Is on the Research Team?

Jeff Kraakivk, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for people aged 45-85 with moderate-stage Parkinson's disease who respond to levodopa, are on stable PD meds, and can walk unassisted. They must be able to use technology, live near the clinic, and not be in other trials or have conditions that could interfere.

Inclusion Criteria

My Parkinson's disease is at a moderate stage.

I respond well to levodopa.

I have been diagnosed with Parkinson's disease by a specialist.

Exclusion Criteria

Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age

I have had brain surgery or have a neurostimulator.

Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive both active and sham Vibrotactile Coordinated Reset stimulation in a crossover design

2 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Follow-up assessments at 3 and 5 months

What Are the Treatments Tested in This Trial?

Interventions

• Active Vibrotactile Coordinated Reset
• Sham Vibrotactile Coordinated Reset

Trial Overview The study tests a non-invasive device called Vibrotactile (VT) Touch which delivers vibrotactile coordinated reset stimulation (vCR). It aims to improve motor function in Parkinson's patients and may delay the need for increased dopamine medication.

How Is the Trial Designed?

Group I: Active vibrotactile coordinated reset Active Control 1 Intervention

Participants will receive active Vibrotactile Coordinated Reset stimulation.

Group II: Sham vibrotactile coordinated reset Placebo Group 1 Intervention

Participants will receive inactive Vibrotactile Coordinated Reset stimulation.

Who Is Running the Clinical Trial?

Synergic Medical Technologies, Inc.

Lead Sponsor

Trials

3

Recruited

100+

Published Research Related to This Trial

The PDShoe is a new vibratory feedback device designed to help improve gait in individuals with Parkinson's disease by providing adjustable vibratory cues during daily activities.

A preliminary evaluation with four Parkinson's disease patients and two healthy subjects demonstrated the usability of the PDShoe, indicating its potential for enhancing mobility in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. Winfree, KN., Pretzer-Aboff, I., Hilgart, D., et al.[2020]

In two feasibility studies involving eight Parkinson's disease patients, both regular and noisy vibrotactile coordinated reset (vCR) stimulation significantly improved motor abilities without any reported side effects.

EEG recordings from one study indicated that noisy vCR therapy led to a significant reduction in high beta power in the sensorimotor cortex, suggesting it effectively modulates neuronal activity related to motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Pfeifer, KJ., Kromer, JA., Cook, AJ., et al.[2023]

Coordinated reset stimulation (CRS) can effectively reduce abnormal brain synchronization associated with Parkinson's disease, as shown in pre-clinical and clinical studies involving parkinsonian monkeys and patients.

The study introduces noninvasive CRS methods using vibrotactile stimulation on fingertips, targeting various mechanoreceptors, which could provide a new avenue for therapeutic intervention in brain disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrotactile Coordinated Reset Stimulation for the Treatment of Neurological Diseases: Concepts and Device Specifications. Tass, PA.[2020]

Vibrotactile Feedback (VF) using a portable device did not significantly improve conversational vocal intensity in real-life settings for individuals with Parkinson's disease, based on a study involving 8 participants over 4 weeks.

There was no notable difference in vocal intensity between VF combined with Lee Silverman Voice Treatment (LSVT LOUD®) and VF alone, indicating that both treatments may have limited effectiveness in enhancing vocal intensity for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. Konnai, R., Van Harn, M., Silbergleit, A.[2023]

A study involving 44 participants with Parkinson's disease found that a novel wearable vibrotactile stimulation device was safe and well tolerated, showing a moderate reduction in resting tremor severity (p < 0.001).

Both high amplitude patterned and low amplitude continuous vibration paradigms were effective in reducing tremor, with no significant difference in effectiveness between the two methods (p = 0.14).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. Tabacof, L., Braren, S., Patterson, T., et al.[2021]

A novel vibrotactile stimulation device that delivers rhythmic stimuli to the sternum significantly reduced freezing of gait (FOG) episodes in two patients with Parkinson's disease, improving their mobility as measured by the Timed Up and Go test.

The combination of focused vibrotactile stimulation and cueing was effective in alleviating FOG symptoms, suggesting a potential new approach for managing this common issue in Parkinson's disease, though further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. Tan, XS., Pierres, F., Dallman-Porter, A., et al.[2021]

A new non-invasive treatment called vibrotactile coordinated reset (vCR) aims to improve motor and non-motor symptoms in Parkinson's disease (PD) patients by delivering gentle vibrations to the fingertips, with a 7-month study involving 30 participants to assess its efficacy.

The study will measure the effects of vCR on motor abilities using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other evaluations, with the goal of providing evidence for FDA clearance of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Pfeifer, KJ., Cook, AJ., Yankulova, JK., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05881460

Vibrotactile Coordinated Reset: a Non-invasive Treatment ... 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 ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8636796/

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... A previous study has shown that vCR can desynchronize abnormal brain rhythms within the sensorimotor cortex of PD patients, corresponding to ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06559098

Vibrotactile Coordinated Reset (vCR) for the Treatment of ... 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, ...

4. withpower.com withpower.com/trial/phase-parkinson-disease-4-2023-2e5f2

Vibrotactile Stimulation for Parkinson's Disease Research shows that Vibrotactile Coordinated Reset (vCR) can reduce abnormal brain rhythms in Parkinson's patients, leading to improved motor function after ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8055937/

Coordinated Reset Vibrotactile Stimulation Induces Sustained ... Results. Clinically, in both studies, we observed significantly improved motor ability. EEG recordings observed from study 1 indicated a ...

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.758481/full

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... Our primary outcome measure is the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III off medication after 6 months of ...