Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT05117502
Eligibility Criteria:
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* Neurostimulants that cannot be safely withdrawn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; Inconsistency 8)
* RBANS Total Scale \< 70
* History of/or symptoms of psychotic spectrum disorders (i.e., bipolar, schizophrenia)
* Persons with alcohol use disorder (AUD) and/or substance use disorder (SUD) diagnoses confirmed by clinical and/or scientific experts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05117502
Study Brief:
Protocol Section:
NCT05117502