Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity

NCT04361955 | Completed FDA Device

• 1 other identifier: 20-028
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about how deep brain stimulation (DBS) affects brain activity in those with Parkinson's disease (PD) and essential tremor (ET). The effect of therapeutic and non-therapeutic stimulation settings will be assessed. Additionally, DBS effects in the presence and absence of anti-PD medication will be studied. Also of interest are differences in stimulation effects while at rest versus while performing a task.

Conditions

DBS; Parkinson Disease; Essential Tremor; Healthy

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• characterize and record brain activity

  1\) Characterize the spatial and temporal characteristics of cortical activity evoked in response to deep brain stimulation of the targeted subcortical nucleus. 2) Determine the effect of dopamine replacement therapy (DRT) on the spatial and temporal characteristics of the evoked cortical potentials (PD Patients only). 3) Determine the effect of patient state (rest vs. active) spatial and temporal characteristics of the evoked cortical potentials.

  collected during the 8 hour office visit

Study Arms (4)

PD with DBS on

OTHER

intervention is EEG while at rest and performing tasks, on anti PD medications and off anti PD medications

Other: EEG

PD with DBS off

OTHER

intervention is EMG while at rest and performing tasks, on anti PD medications and off anti PD medications

Other: EMG

ET with DBS on

OTHER

intervention is EEG while performing tasks and at rest

Other: EEG

ET with DBS off

OTHER

intervention is EEG while performing tasks and at rest

Other: EMG

Interventions

EMG OTHER

recordings of muscle electrical activity during nerve stimulation using EMG

ET with DBS off; PD with DBS off

EEG OTHER

recordings of brain activity using EEG

ET with DBS on; PD with DBS on

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 40 and 80 years old
• ability to consent
• diagnosis of idiopathic Parkinson Disease or ET for a duration of at least 4 years
• implanted with DBS (STN, GPi or VIM) for at least 3 months

You may not qualify if:

• secondary Parkinsonism, stroke, or progressive central nervous system disease other than Parkinson's disease or essential tremor
• cognitive impairment meeting criteria for dementia on formal neuropsychological evaluation
• lack of fluency in English which would invalidate cognitive testing
• current alcohol or substance abuse
• hearing or visual impairment precluding sensory or cognitive testing

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Farmer Foundation: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth Baker

  The Cleveland Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study N = 180 participants 60 participants with diagnosis of essential tremor having DBS implanted 70 participants with diagnosis of Parkinson Disease having DBS implanted 50 healthy controls

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: January 31, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

US (1)