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

NCT05881460 | Active Not Recruiting FDA Device

• 1 other identifier: 25412
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

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

  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

  baseline, 2 months, 3 months, 5 months

• Quality of life improvements

  baseline, 2 months, 3 months, 5 months

• Change in freezing severity index

  baseline, 2 months, 3 months, 5 months

Study Arms (2)

Active vibrotactile coordinated reset

ACTIVE COMPARATOR

Participants will receive active Vibrotactile Coordinated Reset stimulation.

Device: Active vibrotactile coordinated reset

Sham vibrotactile coordinated reset

SHAM COMPARATOR

Participants will receive inactive Vibrotactile Coordinated Reset stimulation.

Device: Sham vibrotactile coordinated reset

Interventions

Active vibrotactile coordinated reset DEVICE

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

Active vibrotactile coordinated reset

Sham vibrotactile coordinated reset DEVICE

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

Sham vibrotactile coordinated reset

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Synergic Medical Technologies, Inc.: lead

Study Sites (1)

Oregon Health & Science Institution

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jeff Kraakivk, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a double-blinded, crossover trial, where participants are their own control and receive both active stimulation and sham.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: July 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)