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

NCT ID: NCT04877015

Last Updated: 2022-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2022-10-14

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Vibrotactile Coordinated Reset (vCR)

Participants in this arm will receive active vCR stimulation.

Group Type: ACTIVE_COMPARATOR

Active Vibrotactile Coordinated Reset (vCR)

Intervention Type: 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.

Sham Vibrotactile Coordinated Reset (vCR)

Participants in this arm will receive sham vCR stimulation.

Group Type: SHAM_COMPARATOR

Sham Vibrotactile Coordinated Reset (vCR)

Intervention Type: 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.

Interventions

Active Vibrotactile Coordinated Reset (vCR)

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.

Intervention Type: DEVICE

Sham Vibrotactile Coordinated Reset (vCR)

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.

Intervention Type: DEVICE

Other Intervention Names

VT Brain Glove; VT Brain Glove

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synergic Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Stanford University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Tass, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34867742 (View on PubMed)

Other Identifiers

59621

Identifier Type: -

Identifier Source: org_study_id