Speed of Processing Training in Traumatic Brain Injury

NCT02507271 | Completed

• 1 other identifier: 10-01918
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to test the hypothesis that Speed of Information Processing (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals with acquired brain injuries have speed of information processing deficits as part of the cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the efficacy of computerized cognitive Speed of Information Processing (SIP) training in individuals with ABI. Study participants will be asked to attend two study visits over the course of approximately 13 weeks. Participants will be randomly assigned to either the experimental or control group.

Conditions

Traumatic Brain Injury; Vascular Accident, Brain

Outcome Measures

Primary Outcomes (9)

• Reading ability

  Wechsler Test of Adult Reading (WTAR). The WTAR is a measure that reliably estimates levels of intelligence by asking the participant to read aloud the words on an established reading list.

  Change from baseline after 13 weeks

• Speed of Information Processing

  1\) The Paced Auditory Serial Addition Test (PASAT), which is designed to assess complex mental manipulation by adding the two most recent numbers that are presented auditorily. 2) The Symbol Digit Coding subtest of the CNS-Vital Signs neurocognitive battery, which requires the examinee to type and respond as quickly as possible the appropriate number that matches the special symbol. 3) The Stroop subtest of the CNS-Vital Signs neurocognitive battery: The Stroop Test has three parts to it. A) Read the word that is a name of a color as quickly as possible within 90 seconds. B) Name the color of ink that four X's as quickly as possible within 90 seconds. C) Name the color of the ink that the word is written in. The word is a color of ink that is incongruent to the color of the print. The participant is required to name as many inks as possible within 90 seconds.

  Change from baseline after 13 weeks

• Executive Functions

  1\) Trail Making Test, Part A \& B: This test measures efficiency of visual search and set shifting while alternating between letters and numbers. 2) Wisconsin Card Sorting Test, this test measures mental flexibility, set shifting and hypothesis testing. 3) The Non-Verbal Reasoning subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of non-verbal reasoning and pattern identification.

  Change from baseline after 13 weeks

• Working Memory and Attention

  1\) The Continuous Performance subtest of the CNS- Vital Signs neurocognitive battery. The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer. 2) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target. 3) Four-Parts Continuous performance subtest of the CNS- Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention. In addition to these working memory and attention tasks, a verbal digit-span task, this is a standardized measure of verbal working memory.

  Change from baseline after 13 weeks

• Visual and Verbal Memory

  Verbal memory will be assessed with the Verbal Memory subtest of the CNS- Vital Signs neurocognitive battery. Participants will learn a list of words and then will be assessed for immediate recall and delayed recall.

  Change from baseline after 13 weeks

• Speech Perception

  Participants will be given a hearing screening which will take approximately 5 minutes. Participants will listen to speech sounds, words, or sentences over headphones and will make judgments about what they hear, by speaking a response, pushing a button, typing a response, or touching a computer screen. They will either be asked to make judgments about what they hear (e.g., what was the word) or the voice of the person who spoke.

  Change from baseline after 13 weeks

• Depression

  Beck Depression Inventory -II: This is a standardized instrument for the assessment of depression with a self-report questionnaire. Participants will endorse the level of disturbance which best describe their mood over 21 items that are characteristic of depression

  Change from baseline after 13 weeks

• Anxiety

  Beck Anxiety Inventory: The BAI is a self-report instrument for the assessment of anxiety. The BAI consists of 21 items, each describing a common symptom of anxiety on which the respondent rates how much they have been bothered by the symptoms over the last week

  Change from baseline after 13 weeks

• Cognitive Questionnaire

  The Cognitive Self-Report Questionnaire assesses perceptions of cognitive abilities). The Cognitive Self-Report Questionnaire consists of 25 statements about cognition and mood in everyday life over the past 2 weeks.

  Change from baseline after 13 weeks

Secondary Outcomes (1)

• Neuroimaging

  Change from baseline after 13 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Other: Brain Fitness Program

Control Group

PLACEBO COMPARATOR

Other: Weekly Telephone Contact

Interventions

Brain Fitness Program OTHER

This intervention involves work on a computer by responding to sounds for five hours a week, approximately one hour a day five days a week at the Rusk Institute for Rehabilitation.

Experimental Group

Weekly Telephone Contact OTHER

This intervention involves weekly telephone calls over a period of approximately 8 weeks to inquire about the participant's involvement in cognitively stimulating activities (such as reading, working on the computer, puzzles, etc.)

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild, moderate and severe traumatic brain injury or a cerebral vascular accident (Stroke)
• All subjects will be between the ages of 18 and 70 years
• Free from significant psychiatric history (such as schizophrenia or bipolar disorder), due to the potential influence of such disorders on cognitive functioning
• Free of current alcohol or drug as these factors have been shown to negatively affect cognitive abilities.

You may not qualify if:

• Potential participants will be excluded if they are currently taking benzodiazepines or neuroleptics due to their potential effects on cognition.
• Participant will be excluded if they are unable to comprehend the English language, either verbally or written.
• Participants will be excluded from the magnetic resonance imaging (MRI) scan portion of the study if they contain metal in their body that is not compatible with the MRI scan.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center, Rusk Institute for Rehabilitation

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gerald Voelbel

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2010
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

US (1)