Applying Speed of Processing Training to Individuals With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SPTMS  

Official title:

Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838824
• Other study ID #: RG 4607-A-3
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: December 2021

Study information

• Verified date: March 2022
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scores on standardized tests of processing speed	Standardized neuropsychological tests which be used will be used to determine whether there has been a change in speed of processing.	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)