Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06028477
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford 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. Patients will be followed for 14 months.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Stanford Glove	N/A

Detailed Description

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
• Primary Purpose: Treatment
• Official Title: Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
• Anticipated Study Start Date: Oct 29, 2023
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active stimulation Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR	Device: Stanford Glove; The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.
Sham Comparator: Sham Stimulation Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR	Device: Stanford Glove; The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.

Outcome Measures

Primary Outcome Measures

1. Change in MDS-UPDRS Part III Scale Score [Baseline and month 6]

   Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 92 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Ages 18 or older 2. Diagnosed with idiopathic Parkinson's Disease 3. Fluent in English

1. Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.

2. Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.

Exclusion Criteria:

• 1. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.

1. Pregnancy, breast-feeding or wanting to become pregnant 3. Physical limitations unrelated to PD that would affect motor ratings 4. Has implantation of a medical device 5. Sensory abnormalities of the fingertips

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Vivek P Buch, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vivek P. Buch, Assistant Professor of Neurosurgery, Stanford University
• ClinicalTrials.gov Identifier: NCT06028477
• Other Study ID Numbers: 71954
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of Sep 8, 2023