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OpenTrials
Completed

NCT Number: NCT00714571

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mnemonic strategy training (MST)

Behavioral

Repeated exposure (XP)

Behavioral

Subtracting Cues training

Behavioral

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Emory University

Registry information

Official study title

Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2008
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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