RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-12

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05881460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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) 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

Inclusion Criteria

Exclusion 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.

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)
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

Contacts and Locations

Study Contact

Jeff Kraakevik, MD

CONTACT

503-494-8311

kraakevi@ohsu.edu

Principal Investigator

Jeff Kraakivk, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science Institution

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Synergic Medical Technologies, Inc.

Jeff Kraakivk, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-12

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-07-12

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Parkinson Disease