Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment speed of processing training
Sponsor Kessler Foundation
Collaborator National Multiple Sclerosis Society
Start date November 2011
End date December 2015
Trial size 38 participants
Trial identifier NCT01838824, RG 4607-A-3

Summary

This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), 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 MS 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 MS utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the MS 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 MS could have a profound impact on the population and society as a whole.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Group 1 will receive speed of processing training immediately following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment.
speed of processing 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.
(Experimental)
Group 2 will receive speed of processing training 6 weeks following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment.
speed of processing 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.

Primary Outcomes

Measure
Change in scores on standardized tests of processing speed
time frame: Three points in time: Baseline (week 1), immediately following treatment (Group 1 - week 7, Group 2 - week 13), long-term follow-up (Group 1 - week 13, Group 2 - Week 19)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusions: - diagnosis of Multiple Sclerosis - fluent in English - processing speed impairment (based on evaluation). Exclusions: - 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

Additional Information

Official title Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis
Principal investigator Nancy Chiaravalloti, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Kessler Foundation.