Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05117502 |
| Other study ID # |
N3751-P |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2022 |
| Est. completion date |
September 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This pilot study tests the merits of a unique research approach, transdiagnostic sampling.
For Veterans with similar levels of cognitive impairments cause by different types of brain
injuries (stroke or traumatic brain injury), this study examines effects of two cognitive
restorative treatments. Instead of using the traditional approach to examine treatment
effects strictly by cause of brain injury, the transdiagnostic sampling approach recognizes
that cause of injury does not drive treatment responsiveness of recovery.
Description:
The purpose of this study is to identify the supports and barriers to scalability of
Veteran-tailored iTBS and APT across neurologic conditions, with the longer-term goal of
providing an empirical basis for the tailoring of a broader range of cognitive rehabilitation
strategies to optimize each Veteran's cognitive function in daily life. After Veterans
receive standard cognitive rehabilitation, cognitive impairments often persist and if they do
make gains there is limited carry-over to daily function. The tenets of precision
neurorehabilitation suggest that tailored interventions will optimize gains and carry-over,
but precision-tailoring of cognitive rehabilitation will only be possible if researchers
develop and test scalable approaches for identifying, organizing, and analyzing the multitude
of Veteran-specific variables driving and influencing treatment responsiveness. This project
addresses long-standing scientific barriers to understanding treatment responsiveness,
particularly study sample heterogeneity and individual variability. The investigators address
study sample heterogeneity by linking Veterans, across TBI and ischemic stroke, according to
levels of cognitive impairment. The investigators create a cohort of Veterans with a
homogeneous level of cognitive impairment, thereby enabling explication of person-centric
factors influencing treatment responsiveness and carry-over to daily function. Advancing
understanding of the basic study design elements will be achieved by leveraging the knowledge
of intermittent Theta Burst Stimulation (iTBS) and iTBS paired with Attention Processing
Training exercises (iTBS + APT). iTBS is advantageous as it robustly improves working memory
with just one treatment session. These interventions, together, are advantageous as they can
each be tailored to a Veteran's unique cognitive challenges and to target the neural site,
unique to each Veteran's neuropathology. These two interventions also directly address
cognitive deficits, while simultaneously inducing neuroplasticity in neural regions hampered
or impaired by neural injury. The investigators will study Veterans with moderately impaired
cognition who, after standard cognitive rehabilitation, continue to struggle with daily life
requiring assistance with complex instrumental activities of daily living (IADL). Veterans
will participate in a series of two within-subject treatment studies, conducted on two
separate days, 2-weeks apart. Veterans will be randomly assigned to first receive a single
session of Active iTBS or Placebo iTBS and then they will receive APT paired with their
assigned iTBS (Active iTBS + APT vs Placebo iTBS + APT). The investigators will test if
diagnosis moderates the effects of these interventions on both immediate and persisting
change in cognition. For immediate effects, the investigators use a novel testing battery and
for persisting gains the investigators use established and feasible neuropsychological tests
as well as an established test of cognitive function during IADL. Results will be used to
obtain pilot data and examine feasibility in terms of study attrition relative to Veteran
fatigue, mood, and Veteran reports of suitability of key aspects of the study design. These
findings will be used to develop a future merit within-subject cross-over study examining the
over-arching hypothesis that tailored iTBS and APT applied to a transdiagnostic sample and
subsequently matched to a Veteran, according to a biotype algorithm, will result in better
functional performance of Veteran-valued IADL.
