Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active vibrotactile coordinated reset | Active Comparator | Participants will receive active Vibrotactile Coordinated Reset stimulation. |
|
| Sham vibrotactile coordinated reset | Sham Comparator | Participants will receive inactive Vibrotactile Coordinated Reset stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active vibrotactile coordinated reset | Device | 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. |
| 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 2 months between active and sham. Range is 0-72 (18 items with 4 being max for each item), higher being worse | baseline, 2 months, 3 months, 5 months |
| 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 2 months between active and sham | baseline, 2 months, 3 months, 5 months |
| Quality of life improvements |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeff Kraakivk, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science Institution | Portland | Oregon | 97239 | United States |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
This study is a double-blinded, crossover trial, where participants are their own control and receive both active stimulation and sham.
Not provided
Not provided
Not provided
|
| Sham vibrotactile coordinated reset | Device | 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. |
|
|
Quality of life improvements as measured by the Parkinson's disease Quality of Life questionnaire (PDQ-39)
| baseline, 2 months, 3 months, 5 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, 2 months, 3 months, 5 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |