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

Synergic Medical Technologies

Status: Terminated

Conditions: Parkinson Disease

Treatments: Device: Active Vibrotactile Coordinated Reset (vCR); Device: Sham Vibrotactile Coordinated Reset (vCR)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04877015

59621

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Active Vibrotactile Coordinated Reset (vCR)

Active Comparator group

Description:

Participants in this arm will receive active vCR stimulation.

Treatment:

Device: Active Vibrotactile Coordinated Reset (vCR)

Sham Vibrotactile Coordinated Reset (vCR)

Sham Comparator group

Description:

Participants in this arm will receive sham vCR stimulation.

Treatment:

Device: Sham Vibrotactile Coordinated Reset (vCR)