Clinical trial NCT04877015: Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Official title: Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Synergic Medical Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2021-05-07
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.

Detailed description: Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients

Eligibility criteria: 1. Between the ages of 45-85
2. Diagnosis of idiopathic Parkinson's disease
3. Bilateral impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state
4. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor improvement greater than or equal to 30% when on medication compared to when off medication.
5. Participants must be on stable dose of dopaminergic medication for 1 month prior to baseline visit.
6. Able to provide informed consent.
7. Appropriate social support if required during an off state.
8. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
9. Participants must speak English and can communicate with staff without the need of an interpreter.
10. If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recordings

Exclusion Criteria

1. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism.
2. Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc...).
3. Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies.
4. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
5. Physical limitations unrelated to Parkinson's disease.
6. Speech problems or excessive drooling so severe patient cannot communicate properly to staff.
7. Presences of dopamine dysregulation syndrome.
8. On dopamine agonist(s) and exhibits compulsive behaviors.
9. Current delirium
10. Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study.
11. History of epilepsy or traumatic brain injury.
12. Brain surgery (i.e. DBS implantation) or craniotomy.
13. Neurostimulator.
14. A type of hairstyle that would impede the use of a EEG cap
15. Severe sensory abnormalities of the fingertips such as vibratory urticaria.
16. Current or ongoing hallucinations, delusions.
17. The PI and study's neurologist deems the patient ineligible.
18. Patient has a functional movement disorder that prevents accurate Parkinson's disease evaluations

Primary outcomes:
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
timeFrame: 14months
Secondary outcomes:
measure: Spontaneous electroencephalography (EEG)
timeFrame: 7 months
measure: Sensorimotor task EEG
timeFrame: 7 months
measure: Vibration-only evoked EEG potentials
timeFrame: 7 months
measure: PD Quality of Life Questionnaire-39 (PDQ-39)
timeFrame: 14 months
measure: Parkinson's disease sleep scale (PDSS)
timeFrame: 14 months
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: 7 months
measure: Vibratory temporal discrimination task (VTDT)
timeFrame: 7 months
measure: Speech and voice assessments
timeFrame: 7 months
measure: Kinesia One motor evaluation
timeFrame: 14 months
measure: Levodopa equivalent daily dose (LEDD)
timeFrame: 14 months
measure: Freezing of Gait Questionnaire
timeFrame: 14 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Peter Tass, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfeifer KJ, Cook AJ, Yankulova JK, Mortimer BJP, Erickson-DiRenzo E, Dhall R, Montaser-Kouhsari L, Tass PA. Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Front Neurol. 2021 Nov 18;12:758481. doi: 10.3389/fneur.2021.758481. eCollection 2021.