Applying Speed of Processing Training to Individuals With Traumatic Brain Injury (SPTTBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Speed of Process Training
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Processing Speed, Intervention, Traumatic Brain Injury, Cognition
Eligibility Criteria
Inclusion Criteria:
- fluent in English
- processing speed impairment (based on evaluation).
Exclusion Criteria:
- currently taking steroids and /or benzodiazepines
- prior stroke or neurological disease
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- significant alcohol or drug abuse history
Sites / Locations
- Kessler Foundation
Outcomes
Primary Outcome Measures
Processing Speed Performance
Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01838811
Brief Title
Applying Speed of Processing Training to Individuals With Traumatic Brain Injury
Acronym
SPTTBI
Official Title
Applying Speed of Processing Training (SPT) to Individuals With TBI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Processing Speed, Intervention, Traumatic Brain Injury, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Speed of Process Training
Intervention Description
SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. These training tasks are tailored to each individual's ability by the trainer.
Primary Outcome Measure Information:
Title
Processing Speed Performance
Description
Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.
Time Frame
week 6 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
fluent in English
processing speed impairment (based on evaluation).
Exclusion Criteria:
currently taking steroids and /or benzodiazepines
prior stroke or neurological disease
history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
significant alcohol or drug abuse history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Chiaravalloti, Ph.D.
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
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Applying Speed of Processing Training to Individuals With Traumatic Brain Injury
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