Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04361955 |
| Other study ID # |
20-028 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2020 |
| Est. completion date |
August 10, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 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
specific aims.
