Foundations in Developing Precision Cognitive Restoration
Stopped: PI Retirement and no one completed the consent process
United States0Started 2022-02-24
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of TBI or Ischemic Stroke
* 2-10 years post neurologic event having completed rehabilitation
* Age 18 - 80 years old
* Medically stable
* Fluent in English
* Moderately impaired cognitive function as defined by AMPS Processing sub-scale measures falling below 1.0 logits
* Moderately impaired cognitive capacity as defined by having two or more scores falling 1 standard deviation below age normed expectations on: the RBANS index scores, DKEFS Color-Word Trials 3 and 4 scale scores, and/or WAIS-IV Digit Span scaled score
Exclusion Criteria:
* Have BOTH TBI and Ischemic Stroke
* Intracranial lesions or hemorrhagic stroke
* Other primary neurologic diagnosis
* Any dementia diagnosis
* Reside in an extended care facility
* Less than 2 years post TBI or ischemic stroke
* Anti-epileptic medications for seizure activity
* Seizure within the past 3 months or active seizure
* Contraindications to MRI/iTBS
* Medication changes within 3 months of starting participation
* Currently receiving therapy services
* Pregnancy
* FIM scores for problem solving \<3 or \>4 OR memory \<4 or \>5, or changes in FIM scores during screening process
* Neurostimulants that cannot be safely withdrawn
* Bilateral ischemic stroke
* Mild or severe impairments in cognitive capacity or cognitive function
* CHF, implanted pacemakers or defibrillators, or cochlear implants
* Questionable test validity as indicated by DOT (E-score 17) or BRIEF (Negativity 6; Infrequency 3; Inconsi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Streamlined Assessment of Motor and Process Skills (s-APMS) Change 5 timepoints: before and after 1st and 2nd session, then follow up
Timeframe: 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up