Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04997278 |
Other study ID # |
44884 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 12, 2021 |
Est. completion date |
September 5, 2023 |
Study information
Verified date |
September 2023 |
Source |
Stanford University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to evaluate whether a new spinal cord stimulation paradigm, called
Coordinate Reset (CR) Stimulation, can provide equivalent or better pain relief with reduced
energy requirements. The investigators will test this new stimulation paradigm in patients
who are already undergoing spinal cord stimulation surgery. The investigators will also study
whether there are changes in electroencephalography (brain waves) associated with this new
stimulation paradigm.
The investigators hope to learn whether CR stimulation can provide equivalent or better pain
relief with reduced energy requirements. They also hope to learn whether there are changes in
brain function with effective CR stimulation compared to conventional stimulation.
This study will be testing a specific stimulation paradigm in people who have already
consented to have spinal cord stimulation performed for treatment of their chronic pain.
Description:
Study subjects will be identified from the pool of candidates for spinal cord stimulation
(SCS) therapy at Stanford University. Subjects will have undergone a successful trial of
Boston Scientific spinal cord stimulation and will either be candidates for permanent
stimulator implantation, or will have already undergone implantation. Ten subjects will be
recruited over a one year period.
Following informed consent, subjects will be assessed to assure that they meet the criteria
for study entry. All subjects will undergo SCS implantation and will be optimized on standard
SCS (sSCS) settings using the standard clinical protocol, including paresthesia mapping,
threshold finding, and adjustment of stimulation parameters to provide reduction in pain.
Therapeutic sSCS will be maintained for a minimum of one month prior to baseline assessment.
Baseline assessments will be conducted following discontinuation of SCS for 24 hours. This
assessment battery includes a physical and neurological exam, visual analog scale (VAS)
score, Oswestry Disability Index, SF-12 and Global Assessment of Functioning, as well as EEG
recordings (spontaneous EEG recording + dedicated pain-related evoked response recording).
Following this baseline assessment, sSCS will be delivered for one month. Stimulation
parameters will be held constant for the last 7 days of this period. During this time,
subjects will use the CamNtech Pro-Diary wrist-worn data entry system to rate their back
pain, leg pain and overall pain (3 questions), 3 times per day (morning, afternoon evening).
The Pro-Diary allows for configurable, portable data entry as well as actigraphy.
The full assessment battery will be repeated, and the stimulator deactivated.
Following a washout period of three hours, VAS and EEG recordings will be performed. CR-SCS
will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform
this upgrade. The stimulator will then be programmed to deliver CR-SCS. At the end of one
month of CR-SCS (with stimulation parameters similarly held constant for the last 7 days),
the assessment battery will be repeated, and VAS and EEG recordings will again be performed
after a three hour washout period. Finally, a firmware downgrade will be performed by Boston
Scientific Personnel, and patients will be treated with sSCS at their previous settings.