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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active vibrotactile coordinated reset
Sham vibrotactile coordinated reset
Sponsored by
Synergic Medical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Oregon Health & Science InstitutionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active vibrotactile coordinated reset

Sham vibrotactile coordinated reset

Arm Description

Participants will receive active Vibrotactile Coordinated Reset stimulation.

Participants will receive inactive Vibrotactile Coordinated Reset stimulation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Quality of life improvements
Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)
Change in freezing severity index
Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters

Full Information

First Posted
May 19, 2023
Last Updated
July 13, 2023
Sponsor
Synergic Medical Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05881460
Brief Title
Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease 2
Official Title
Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
September 21, 2024 (Anticipated)
Study Completion Date
January 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synergic Medical Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is a double-blinded, crossover trial, where participants are their own control and receive both active stimulation and sham.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active vibrotactile coordinated reset
Arm Type
Active Comparator
Arm Description
Participants will receive active Vibrotactile Coordinated Reset stimulation.
Arm Title
Sham vibrotactile coordinated reset
Arm Type
Sham Comparator
Arm Description
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.
Intervention Type
Device
Intervention Name(s)
Active vibrotactile coordinated reset
Other Intervention Name(s)
VT Touch glove
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham vibrotactile coordinated reset
Other Intervention Name(s)
VT Touch glove
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Description
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
Time Frame
baseline, 4 months, 5 months, 9 months
Secondary Outcome Measure Information:
Title
Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab
Description
Difference in APDM gait speed from baseline to 4 months between active and sham
Time Frame
baseline, 4 months, 5 months, 9 months
Title
Quality of life improvements
Description
Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)
Time Frame
baseline, 4 months, 5 months, 9 months
Title
Change in freezing severity index
Description
Change in freezing severity index quantified during a turning in place task and other gait spatio-temporal parameters
Time Frame
baseline, 4 months, 5 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeff Kraakevik, MD
Phone
503-494-8311
Email
kraakevi@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Kraakivk, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science Institution
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Kraakevik, MD
Phone
503-494-8311
Email
kraakevi@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jacquie Ellison
Phone
503-418-2602
Email
ellisoia@ohsu.edu

12. IPD Sharing Statement

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

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