Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Speed of Processing Training to Improve Cognition in Multiple Sclerosis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02301260
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Nancy Chiaravalloti, Kessler Foundation

Brief Summary:
The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life. This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Speed of Processing Training (SPT) Behavioral: Placebo Control Not Applicable

Detailed Description:
This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS. This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures. In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other. This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Speed of Processing Training (SPT)
SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
Behavioral: Speed of Processing Training (SPT)
Placebo Comparator: Placebo control group
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions)
Behavioral: Placebo Control
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).




Primary Outcome Measures :
  1. Change in scores on standardized tests of processing speed [ Time Frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed ]

Secondary Outcome Measures :
  1. Change in scores on self-report of emotional functioning, measured via questionnaire [ Time Frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed ]
    Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.

  2. Change in scores on self-report of everyday functioning, measured via questionnaire [ Time Frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed ]
  3. Change in scores on self-report of quality of life, measured via questionnaire [ Time Frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English as a primary language
  • diagnosis of Multiple Sclerosis
  • processing speed impairment (based on evaluation)

Exclusion Criteria:

  • most recent exacerbation within one month
  • currently taking steroids or benzodiazepines
  • history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
  • 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): NCT02301260


Locations
Layout table for location information
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Angela Smith, MA    973-324-8448    asmith@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
National Multiple Sclerosis Society
Investigators
Layout table for investigator information
Principal Investigator: Nancy Chiaravalloti, PhD Kessler Foundation

Layout table for additonal information
Responsible Party: Nancy Chiaravalloti, Director, Neuropsychology and Neuroscience Laboratory, Kessler Foundation
ClinicalTrials.gov Identifier: NCT02301260     History of Changes
Other Study ID Numbers: RG 4997A5/1
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Nancy Chiaravalloti, Kessler Foundation:
Processing Speed
Intervention
Multiple Sclerosis
Cognition

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple 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