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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01838824
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Speed of Processing Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis
Study Start Date : November 2011
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Speed of Processing Training - Group 1
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
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: Speed of Processing Training - Group 2
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
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 Outcome Measures :
  1. 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) ]
    Standardized neuropsychological tests which be used will be used to determine whether there has been a change in speed of processing.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838824


Locations
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United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
National Multiple Sclerosis Society
Investigators
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Principal Investigator: Nancy Chiaravalloti, PhD Kessler Foundation

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Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology & Neuroscience Lab, Kessler Foundation
ClinicalTrials.gov Identifier: NCT01838824    
Other Study ID Numbers: RG 4607-A-3
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Processing Speed
Intervention
Multiple Sclerosis
Cognition
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors