NCT02020564

Brief Summary

The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

10.1 years

First QC Date

December 19, 2013

Last Update Submit

January 16, 2023

Conditions

Traumatic Brain InjuryMild Cognitive Impairment

Keywords

Processing SpeedCognitionInterventionTraumatic Brain InjuryMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Symbol-Digit Modalities Test

    Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test

    Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Secondary Outcomes (3)

  • TBI Quality of Life, Depression scale

    Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

  • Perceived Deficits Questionnaire

    Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

  • TBI Quality of Life, Total Score

    Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Study Arms (2)

Treatment Group

EXPERIMENTAL

Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Speed of Processing Training

Placebo control group

PLACEBO COMPARATOR

Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Placebo Control

Interventions

Speed of Processing TrainingBEHAVIORAL
Treatment Group
Placebo ControlBEHAVIORAL
Placebo control group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of Traumatic Brain Injury or Mild cognitive impairment
  • Fluent in English
  • processing speed impairment

You may not qualify if:

  • prior stroke or neurological disease
  • currently taking steroids and/or benzodiazepines
  • history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
  • significant alcohol or drug abuse history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Goverover Y, Costa SL, DeLuca J, Chiaravalloti N. Does speed of processing training improve everyday life functional activity in traumatic brain injury: A pilot randomized controlled trial. Neuropsychol Rehabil. 2025 Jul 4:1-16. doi: 10.1080/09602011.2025.2526663. Online ahead of print.

    PMID: 40615123DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuropsychology & Neuroscience; Director, Traumatic Brain Injury Research

Study Record Dates

First Submitted

December 19, 2013

First Posted

December 25, 2013

Study Start

December 12, 2012

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

US(1)