Vibrotactile Stimulation for Parkinson's Disease

July 1, 2026 updated by: University of Colorado, Denver
Investigation on whether and how vibrotactile stimulation applied on the fingertips affects beta power in the subthalamic nucleus.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

With a randomized order, two stimulation patterns are applied for one hour each on the fingertips of Parkinson's patients with deep brain stimulation, while periodically recording from subthalamic nucleus (STN) local field potentials (LFPs). The randomized vibrotactile stimulation (RVS) power is expected to reduce neuronal synchronization and LFP beta power. The All-on stimulation pattern is not expected to reduce neuronal synchronization and LFP beta power.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80045
        • CTRC Space, Health Sciences Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The population to be enrolled will be between 18 and 85 years of
  • Have a diagnosis of idiopathic Parkinson's disease, determined by a movement disorders neurologist at the CU Movement Disorders Center
  • Has undergone deep brain stimulation surgery at the University of Colorado hospital

Exclusion Criteria:

  • have severe sensory abnormalities of the fingertips such as vibratory urticaria
  • Patients that cannot clearly communicate with staff and speak English
  • Patients that are on psychoactive or narcoleptic medications, medications that affect brain function or alter EEG recorded activity (i.e., anticonvulsants, ADHD, depression, or anxiety medication)
  • Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RVS and All-on sequence
Participants receives the RVS stimulation pattern followed by the All-on pattern
Vibration patterns applied on the fingertips.
Experimental: All-on and RVS sequence
Participants receives the All-on stimulation pattern followed by the RVS pattern
Vibration patterns applied on the fingertips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beta band power
Time Frame: At baseline (pre-intervention) and after 30 min of intervention
13-30 Hz frequency band
At baseline (pre-intervention) and after 30 min of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS Part III
Time Frame: At baseline (pre-intervention) and 1-hour of intervention
Movement disorder assessment for Parkinson's disease motor symptoms of the upper extremity. The scale is from 0 to 4 for the items in the MDS-UPDRS Part III, where 0 represents normal function (and 4 is worse).
At baseline (pre-intervention) and 1-hour of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

August 12, 2025

Study Completion (Actual)

August 16, 2025

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified data will be shared on github.

IPD Sharing Time Frame

Available by the paper is published.

IPD Sharing Access Criteria

The data will be available as open-source.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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