Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05555485 |
Other study ID # |
22-0187 |
Secondary ID |
1RM1NS128787-01 |
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 24, 2023 |
Est. completion date |
September 30, 2027 |
Study information
Verified date |
May 2023 |
Source |
The University of Texas Medical Branch, Galveston |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to find out how a stimulation device worn on the ear works. This
device is thought to stimulate nerves in the area around the ear to change the signals in the
brain. The device has been shown to reduce pain and to reduce the symptoms of withdrawal. The
investigator will also investigate changes in the way each participant perceive sensations of
pressure and heat. The participant will be asked to reduce the amount of pain medication that
they take. Then, the participant will spend several days and nights in the Clinical Research
Center at UTMB (University of Texas Medical Branch) in Galveston. During that time, the
participant will be monitored for withdrawal symptoms and will receive either active (e.g.,
"real") brain stimulation or sham (e.g., "fake") brain stimulation for two days (four hours
each day). At two times over the course of the study (before and after ear stimulation
treatment), the participant will complete questionnaires about their pain score and how they
are feeling, sensory testing, and will undergo magnetic resonance imaging (MRI) of their
brain. The investigator will collect the following information from the participant's medical
record: age, gender, medication history, medical diagnoses, recent vital signs, past doctor
visits or hospital stays, and results of urine drug tests. Participation in this study will
last approximately four days, and the participant will stay in the Clinical Research Center.
Description:
Rationale and Aims
The current project will build on the previous tAN (transcutaneous auricular
neurostimulation) research and clinical studies on chronic pain and opioid withdrawal,
ultimately providing a "neural blueprint" of how tAN therapy can mitigate pain and opioid
withdrawal symptoms. The investigators will conduct a clinical mechanistic trial of tAN in
chronic pain patients tapering from therapeutic opioids. The study will accomplish the
following Aim and address the following hypotheses:
Aim: Establish the functional MRI (fMRI) neurophysiological signature specifically underlying
tAN-based analgesia in chronic pain participants undergoing an opioid taper.
Hypothesis 1: Chronic pain participants who receive tAN stimulation will demonstrate
increased fMRI signal activation in vagal afferents within the brainstem compared to sham
treatment.
Hypothesis 2: Chronic pain participants who receive tAN will demonstrate decreased fMRI
signal activation in the cortical and subcortical pain network compared to sham treatment.
Exploratory Hypothesis 1: tAN-based changes in brain activation will correlate with measures
of pain, and the severity of depression and anxiety to specifically delineate the overlay and
distinguishing factors between the brain signatures of analgesia, and discomfort.
Study Summary On Day 1 at the CRC (Clinical Research Center), the investigators will review
the consent and obtain consent. the investigators will reduce the amount of pain medication
on the first day and continue for four days. The reduction in dose will be 10-20% of the
participants daily pain medication dose. The participant will complete questionnaires, submit
a UDS, MRI, and sensory testing. On Day 2, the participant will be randomly assigned to
receive either active, (real) brain stimulation or sham (fake) brain stimulation. The
participant have an equal chance of being assigned to either group (similar to flipping a
coin). Sham brain stimulation will look and feel like active stimulation. The participant
will not be able to tell which type of stimulation is received until the participant complete
the study. Brain stimulation will be delivered on the second and third days of the study for
approximately four hours each day (e.g., four sessions of stimulation for one hour each day).
On Day 3, the participant will receive four hours of stimulation. On Days 2 and 3, the
participant will have your heart rate, blood pressure, and breathing rate measured; and will
complete withdrawal symptom questionnaires and will give a pain score every four hours from
8am to 8pm. The researchers will not disturb participants at night. On Day 4, the participant
will complete questionnaires, MRI, and sensory testing. The stimulation device will be
returned to study personnel at the end of the study. The participant's pain physician can
contact Spark Biomedical and prescribe the stimulation device for continued use at home.