RECRUITINGINTERVENTIONAL
Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease 2
Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form
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.
Who Should NOT Join This Trial:
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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
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.
Locations (1)
Oregon Health & Science Institution
Portland, Oregon, United States