Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease 2
NCT ID: NCT05881460
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-07-12
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Active vibrotactile coordinated reset
Participants will receive active Vibrotactile Coordinated Reset stimulation.
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.
Sham vibrotactile coordinated reset
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
\*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
45 Years
85 Years
ALL
No
Sponsors
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Synergic Medical Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Kraakivk, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health & Science Institution
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25412
Identifier Type: -
Identifier Source: org_study_id