- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687732
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
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-1855
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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