Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment

NCT ID: NCT02020564

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-12

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.

Conditions

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Traumatic Brain Injury Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

Speed of Processing Training

Intervention Type BEHAVIORAL

Placebo control group

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

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type BEHAVIORAL

Interventions

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Speed of Processing Training

Intervention Type BEHAVIORAL

Placebo Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Nancy Chiaravalloti

Director, Neuropsychology & Neuroscience; Director, Traumatic Brain Injury Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40615123 (View on PubMed)

Other Identifiers

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R-755-12

Identifier Type: -

Identifier Source: org_study_id

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