Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02553525 |
| Other study ID # |
Pro00074235 |
| Secondary ID |
R37NS040894 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2, 2016 |
| Est. completion date |
September 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to measure the effects of non-regular temporal patterns of deep
brain stimulation (DBS) on motor symptoms and neural activity in persons with Parkinson's
disease (PD), essential tremor (ET), dystonia or multiple sclerosis (MS). These data will
guide the design of novel stimulation patterns that may lead to more effective and reliable
treatment with DBS. These data will also enable evaluation of current hypotheses on the
mechanisms of action of DBS. Improving our understanding of the mechanisms of action of DBS
may lead to full development of DBS as a treatment for Parkinson's disease and may lead to
future applications of DBS.
Description:
This study will be conducted in the operating rooms at Duke University Medical Center, Emory
University Hospital, University of Florida Shands Hospital or the UF Health Florida Surgical
Center. The study will be performed during surgery on subjects who are undergoing
implantation of the deep brain stimulation (DBS) system, or on subjects who are receiving
surgical replacement of the implanted pulse generator (IPG) due to depleted batteries.
Subjects will receive temporary sterile extensions to the DBS electrode. These temporary
extensions will connect to a stimulation and recording system and allow recording of neural
activity. Over the course of ~45 minutes different non-regular temporal patterns of
stimulation will be delivered unilaterally and the effects on neural activity and movement
disorder symptoms will be measured. The stimulus waveform will be a charge-balanced biphasic
pulse, with charge restricted to values below the limit set by the DBS IPG manufacturer, 30
μC/cm². After the study is completed, the temporary extensions will be removed, and the
ordinary clinical conduct of the procedure will continue for treatment of the patient's
movement disorder.
Tremor will be measured using an accelerometer in subjects with essential tremor (ET),
multiple sclerosis (MS) and tremor-dominant Parkinson's disease (PD). Bradykinesia will be
measured using a finger-tapping task on a computer mouse in subjects with Parkinson's disease
who do not have dominant tremor symptoms. Subjects will be familiarized with the motor
symptom evaluation tasks before surgery, and baseline measurements of tremor or bradykinesia
may be recorded. Further, they may be asked to discontinue use of anti-parkinsonian and/or
anti-tremor medications overnight prior to the study, to reduce variability of motor symptoms
due to the time course of medications.
No general anesthesia will be given to subjects during surgery, and the procedure will be
performed under local anesthesia to allow subjects to perform the tasks required in this
study. Further, no sedation will be given to subjects receiving a replacement IPG, which can
cause minor discomfort or anxiety in some patients. Subjects undergoing surgery for electrode
implantation will receive monitored anesthesia care (MAC), in which sedation will be
administered as needed, such that subjects are still responsive and pathological motor
symptoms (tremor or bradykinesia) are present.
Following surgery, the subject's pre-operative MRI and post-operative high-resolution CT
scans may be used to determine the location of DBS electrode contacts within the brain.
However, participation in the study will not modify imaging procedures needed for standard
care, and placement of the electrode during DBS implant surgery will not be altered by the
research study.
There will be no additional costs to subjects as a result of being in this study. Additional
operating room costs will be covered by institutional and/or grant resources.
