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Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity

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ClinicalTrials.gov Identifier: NCT04361955
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Farmer Foundation
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
DBS Parkinson Disease Essential Tremor Other: EMG, EEG, MEG, MRI Not Applicable

Detailed Description:

Deep brain stimulation (DBS) is a standard-of-care, FDA approved therapy for Parkinson's disease (PD) and tremor and well over 1,000 patients have been implanted at the Cleveland Clinic in the past 20 years. The therapy involves stereotactic implantation of one or more leads into specific sensorimotor brain regions, with each lead consisting of an array of four to eight contacts. The proximal end of the lead is tunneled to an implantable pulse generator (IPG) placed under the skin of the chest. Post-operatively, a health care professional carefully programs the IPG: adjusting the delivery location (i.e., contact selection) and titrating the frequency, amplitude, and width of the stimulus pulses to maximize therapeutic benefit while minimizing any side effects. It is hypothesized that the chronic, electrical stimulation of the target region has both local and circuit-wide effects, the net effect of which is to disrupt the pathophysiological neural activity present across both cortical and subcortical brain regions that is thought to underlie disease manifestation.

Study-related activities will begin in the morning, with participants reporting to the Center for Neurological Restoration outpatient clinic desk in the S-building. Those participants with a diagnosis of Parkinson's disease will be asked to arrive in the "practically defined OFF" state (i.e., will come for testing having taken PD medications as usual up to midnight of the preceding day, and none on the morning of testing). To help to minimize off-medication risks, patients with PD will be offered the option to stay overnight at an on-campus hotel at no cost. Patients will be provided with lunch and additional rest breaks, as needed, throughout the day.

A technician will apply either Ag/AgCl clinical scalp electrodes or an elastic cap pre-populated with electrodes after which electroencephalographic (EEG) activity will be monitored and recorded throughout the remainder of the study. Participants will undergo an initial stimulation threshold evaluation to establish DBS-related sensorimotor side effect thresholds.

Throughout testing, participants will be seated comfortably in a quiet room. Continuous EEG and EMG recordings will be made as the parameters of the patients IPG are systematically modified (i.e., changes in pulse frequency, amplitude, width and active contacts) with the patient at rest and, for specific settings, again while the patient performs a simple, continuous motor task using the upper extremity (e.g., computer-generated sine tracking). Visual and auditory evoked potentials will be elicited using stimuli delivered via goggles (or other light source) and headphones, respectively. Somatosensory evoked potentials will be elicited through electrical stimulation of the median or posterior tibialis nerve using standard clinical techniques at approximately 125% of motor threshold. Event related potentials tasks will include simple and choice reaction time, NoGo, as well as auditory oddball tasks repeated in one or more DBS conditions. Note that the precise order of test administration may be randomized in order to minimize order effects. Also note that patients diagnosed with PD will be instructed to take their usual dose of anti-PD medication approximately mid-way through the test session, after which a subset of the evoked potential testing will be repeated.

In this study, the investigators will use multiple non-invasive physiological metrics, including magnetoencephalography, scalp electroencephalography and surface electromyography, to characterize the spatiotemporal pattern of cortical and corticomuscular modulation associated with therapeutic, non-therapeutic, and side-effect-inducing parameters of DBS to address the following aims:

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: study N = 30 participants 10 participants with diagnosis of essential tremor having DBS implanted 20 participants with diagnosis of Parkinson Disease having DBS implanted
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modulatory Effects of Deep Brain Stimulation on Cerebral Cortical Activity
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
PD with DBS
interventions are EEG, EMG, MEG, MRI while at rest and while performing tasks, while in the off state of medication use and while in the on state of medication use
Other: EMG, EEG, MEG, MRI
recordings of brain activity using EMG, EEG, MEG and MRI

ET with DBS
interventions are EEG, EMG, MEG, MRI while at rest and while performing tasks, while in the off state of medication use and while in the on state of medication use
Other: EMG, EEG, MEG, MRI
recordings of brain activity using EMG, EEG, MEG and MRI




Primary Outcome Measures :
  1. characterize and record brain activity [ Time Frame: collected during the 8 hour office visit ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361955


Contacts
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Contact: Andre G Machado, MD 216-444-4270 machada@ccf.org
Contact: Kenneth Baker, PhD 216-445-2244 bakerk6@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Andre G Machado, MD    216-444-4270    machada@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Farmer Foundation
Investigators
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Study Director: Kathryn O'Connor The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04361955    
Other Study ID Numbers: 20-028
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by The Cleveland Clinic:
deep brain stimulation
Additional relevant MeSH terms:
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Parkinson Disease
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases