Applying Speed of Processing Training to Individuals With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— SPTTBI  

Official title:

Applying Speed of Processing Training (SPT) to Individuals With TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838811
• Other study ID #: KF 30.01
• Status: Completed
• Phase: N/A
• First received: May 11, 2012
• Last updated: April 1, 2015
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Behavioral:
• Speed of Process Training
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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing Speed Performance	Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.	week 6 and week 12	No