Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05889117 |
Other study ID # |
23-110 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 30, 2023 |
Est. completion date |
December 2024 |
Study information
Verified date |
March 2024 |
Source |
The Mind Research Network |
Contact |
Jody Roberts, MS |
Phone |
505-272-5028 |
Email |
jroberts[@]mrn.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to test a new type of magnetic brain stimulation in
patients with persistent post-concussive symptoms. Participants will undergo detailed MRI
scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the
study aims to answer are:
- Will this new type of treatment result in fewer symptoms and better daily functioning?
- What are the effects of this treatment on brain functioning?
Description:
Repetitive transcranial magnetic stimulation (rTMS) seems a promising treatment option for
patients with persistent post-concussive symptoms (PPCS). Traditional rTMS sessions are
relatively long in duration and can be exhaustive for patients with PPCS. Intermittent
theta-burst stimulation (iTBS) is a newer and more rapid form of rTMS, which only takes up to
10 minutes per session. However, little is known about the effects of iTBS in patients with
PPCS. Furthermore, there is a pressing need for methods that reliably measure the effects of
TMS treatments in-vivo. Using diffusion magnetic resonance spectroscopy (dMRS) changes in
neural and glial cell morphology can be quantified, which makes it possible to disentangle
neurometabolic changes related to neural injury and neuroinflammation, two key elements in
the pathophysiology of mTBI.
In the current study, 15 patients with chronic (>3 months after mTBI) PPCS will undergo a
total of 30 iTBS sessions. After a baseline scan, patients will enter a 2-week control
waitlist period. Following the waitlist control, a pre-treatment scan is acquired, followed
by the stimulation sessions, and final post-treatment scan. The scanning protocol includes T1
and T2 imaging, dMRS, multi-shell diffusion MRI (dMRI), as well as a demanding executive
function fMRI task, and resting-state fMRI (rs-fMRI). A comprehensive battery of clinical
tests will be administered at all time points, which includes cognitive testing, self-report
of symptoms and emotional distress. Long-term outcome is determined three months after start
of the study.
Specific study aims are:
Aim 1: To determine the effects of a precision-medicine iTBS guided approach applied to the
left dorsolateral prefrontal cortex (DLPFC) on clinical recovery in patients with PPCS
relative to waitlist control.
Aim 2: To determine the neurometabolic effects of iTBS in both the left and right DLPFC as
measured with dMRS in patients with PPS, and to untangle differential effects on
pathophysiological processes (e.g., neural plasticity vs. anti-inflammatory effects).
Aim 3: To determine the relationship of these neurometabolic effects and the integrity of
major frontoparietal white matter tracts (as measured with dMRI), as well as activation and
functional connectivity of key large-scale cognitive and emotional networks (i.e., executive,
default mode, and salience network), measured using task-based and resting-state fMRI.