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Clinical Trials/NCT07687732
NCT07687732CompletedPhase 1

Vibrotactile Stimulation for Parkinson's Disease

University of Colorado, Denver1 site in 1 country12 target enrollmentStarted: August 23, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Beta band power
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Beta band power

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

13-30 Hz frequency band

Secondary Outcomes

  • MDS-UPDRS Part III(At baseline (pre-intervention) and 1-hour of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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Vibrotactile Stimulation for Parkinson's... | Clinical Trial