Vibrotactile Stimulation for Parkinson's Disease

Overseen by Jeff Kraakivk, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment that uses gentle fingertip vibrations to help people with Parkinson's disease move better. It targets those who have severe side effects from current treatments or find them invasive. The vibrations aim to reset abnormal brain activity to improve movement. Recent studies have suggested that vibration therapy may have a positive influence on motor symptoms in individuals with 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 data supports the effectiveness of the treatment Vibrotactile Coordinated Reset 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 three months of daily treatment. Additionally, a study found that short durations of vibrotactile stimulation reduced resting tremor severity, suggesting potential benefits for Parkinson's symptoms. ^{1 2 3 4 5}

Is vibrotactile stimulation safe for humans?

Research shows that vibrotactile stimulation, used in devices for Parkinson's disease, is generally safe and well tolerated in humans. Studies have found it to be safe when used for short durations and in different stimulation patterns. ^{1 3 4 6 7}

How is the Vibrotactile Coordinated Reset treatment different from other treatments for Parkinson's disease?

The Vibrotactile Coordinated Reset (vCR) treatment is unique because it uses gentle vibrations on the fingertips to non-invasively reduce abnormal brain rhythms, aiming to improve motor symptoms in Parkinson's disease. Unlike traditional treatments, it focuses on desynchronizing neural networks to provide long-lasting relief without medication. ^{1 2 3 4 5}

Research Team

Jeff Kraakivk, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• Active Vibrotactile Coordinated Reset (Behavioural Intervention)
• Sham Vibrotactile Coordinated Reset (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. [2023]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. [2023]