Vibrotactile Stimulation for Parkinson's Disease

NCT07687732 | Completed Early Phase 1

• 1 other identifier: 22-1855
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation on whether and how vibrotactile stimulation applied on the fingertips affects beta power in the subthalamic nucleus.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson's disease; non-invasive stimulation; vibrotactile stimulation

Outcome Measures

Primary Outcomes (1)

• Beta band power

  13-30 Hz frequency band

  At baseline (pre-intervention) and after 30 min of intervention

Secondary Outcomes (1)

• MDS-UPDRS Part III

  At baseline (pre-intervention) and 1-hour of intervention

Study Arms (2)

RVS and All-on sequence

EXPERIMENTAL

Participants receives the RVS stimulation pattern followed by the All-on pattern

Device: Vibrotactile stimulation

All-on and RVS sequence

EXPERIMENTAL

Participants receives the All-on stimulation pattern followed by the RVS pattern

Device: Vibrotactile stimulation

Interventions

Vibrotactile stimulation DEVICE

Vibration patterns applied on the fingertips.

All-on and RVS sequence; RVS and All-on sequence

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

CTRC Space, Health Sciences Building

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: August 23, 2023
• Primary Completion: August 12, 2025
• Study Completion: August 16, 2025
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available by the paper is published.
• Access Criteria: The data will be available as open-source.

Locations

US (1)