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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Active vibrotactile coordinated reset; Device: Sham vibrotactile coordinated reset

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeff Kraakevik, MD; Phone Number: 503-494-8311; Email: kraakevi@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science Institution
      • Contact: Jeff Kraakevik, MD; Phone Number: 503-494-8311; Email: kraakevi@ohsu.edu
      • Contact: Jacquie Ellison; Phone Number: 503-418-2602; Email: ellisoia@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active vibrotactile coordinated reset; Participants will receive active Vibrotactile Coordinated Reset stimulation.	Device: Active 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.; Other Names: VT Touch glove
Sham Comparator: Sham vibrotactile coordinated reset; Participants will receive inactive Vibrotactile Coordinated Reset stimulation.	Device: Sham 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.; Other Names: VT Touch glove

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 4 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse	baseline, 4 months, 5 months, 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab	Difference in APDM gait speed from baseline to 4 months between active and sham	baseline, 4 months, 5 months, 9 months
Quality of life improvements	Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)	baseline, 4 months, 5 months, 9 months
Change in freezing severity index	Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters	baseline, 4 months, 5 months, 9 months

Collaborators and Investigators

• Sponsor: Synergic Medical Technologies, Inc.
• Investigators: Principal Investigator: Jeff Kraakivk, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): September 21, 2024
• Study Completion (Estimated): January 21, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 25412

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No