Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)

VA Office of Research and Development

Status and phase: Completed; Phase 1

Conditions: Traumatic Brain Injury; Alzheimer's Disease; Mild Cognitive Impairment

Treatments: Behavioral: Repeated exposure (XP); Behavioral: Mnemonic strategy training (MST); Behavioral: Subtracting Cues training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00714571

B6366-W

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 6 patient groups

MST healthy older adults Stage 1

Active Comparator group

Description:

Mnemonic strategy training

Treatment:

Behavioral: Mnemonic strategy training (MST)

MST MCI Stage 1

Active Comparator group

Description:

Exposure training

Treatment:

Behavioral: Mnemonic strategy training (MST)

XP healthy older adults Stage 1

Active Comparator group

Description:

XP healthy older adults Stage 1

Treatment:

Behavioral: Repeated exposure (XP)

XP MCI Stage 1

Active Comparator group

Description:

XP MCI Stage 1

Treatment:

Behavioral: Repeated exposure (XP)

MST healthy older adults Stage 2

Active Comparator group

Description:

MST healthy older adults Stage 2

Treatment:

Behavioral: Mnemonic strategy training (MST)

SCT healthy older adults Stage 2

Active Comparator group

Description:

SCT healthy older adults Stage 2

Treatment:

Behavioral: Subtracting Cues training