Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Memory Test Accuracy on Trained Stimuli
Study Overview
Brief Summary
Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following cognitive rehabilitation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 88 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •General inclusion criteria (all patients):
- •A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
- •All medications stable for approximately 3 months;
- •No history of severe mental illness;
- •No current untreated alcohol or substance abuse/dependence;
- •English as native and preferred language;
- •MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.
- •MCI Inclusion Criteria:
- •Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
- •55 years of age or older.
- •TBI Inclusion criteria:
- •History of a mild to moderate TBI;
- •No history of other neurological disease or injury;
- •A minimum of 6 months and maximum of 5 years post-onset of TBI;
- •18 - 45 years old.
Exclusion Criteria
- •History of neurological disease or injury (other than TBI)
- •History of severe mental illness
- •Current untreated alcohol or substance abuse
- •Other conditions may exclude; please discuss with contact
Arms & Interventions
MST healthy older adults Stage 1
Mnemonic strategy training
Intervention: Mnemonic strategy training (MST) (Behavioral)
MST MCI Stage 1
Exposure training
Intervention: Mnemonic strategy training (MST) (Behavioral)
XP healthy older adults Stage 1
XP healthy older adults Stage 1
Intervention: Repeated exposure (XP) (Behavioral)
XP MCI Stage 1
XP MCI Stage 1
Intervention: Repeated exposure (XP) (Behavioral)
MST healthy older adults Stage 2
MST healthy older adults Stage 2
Intervention: Mnemonic strategy training (MST) (Behavioral)
SCT healthy older adults Stage 2
SCT healthy older adults Stage 2
Intervention: Subtracting Cues training (Behavioral)
Outcomes
Primary Outcomes
Memory Test Accuracy on Trained Stimuli
Time Frame: Pre-training, post-training, 1 month
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
Secondary Outcomes
No secondary outcomes reported