Applying Speed of Processing Training to Individuals With Multiple Sclerosis

NCT01838824 | Completed

• 1 other identifier: RG 4607-A-3
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Processing Speed; Intervention; Multiple Sclerosis; Cognition

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Speed of Processing Training - Group 1

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.

Behavioral: Speed of Processing Training

Speed of Processing Training - Group 2

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.

Behavioral: Speed of Processing Training

Interventions

Speed of Processing Training BEHAVIORAL

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.

Speed of Processing Training - Group 1; Speed of Processing Training - Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kessler Foundation: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nancy Chiaravalloti, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuropsychology & Neuroscience Lab

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: April 24, 2013
• Study Start: November 1, 2011
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)