Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis

NCT03306875 | Completed

• 1 other identifier: STUDY00001899
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to apply baseline MRI and neuropsychological measures to predict patient responses to behavioral cognitive rehabilitation. Training will take place over 12 weeks, 1 hour per day, 5 days per week. The investigator hypothesizes the following: \[1a\] The investigator expects that individuals with low baseline Conscientiousness will experience a lower magnitude of overall cognitive improvement following rehabilitation

1. 1.b\] The investigator expects the impact of Conscientiousness on fidelity of rehabilitation will in part be moderated by individual differences in program adherence and executive function
2. 2.a\] The investigator expects that individual differences in structural and functional connectome disturbances will in part explain differences in participant responses to cognitive rehabilitation.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; cognitive training; telerehabilitation; personality; Conscientiousness; predict

Outcome Measures

Primary Outcomes (2)

• Impact of Conscientiousness on Cognitive Training Outcomes

  The investigator expects baseline Conscientiousness to correlate positively with cognitive gains following rehabilitation. Conscientiousness will be measured using the NEO-Five Factor Inventory (NEOFFI). All scores for personality testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units.

  This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation)

• Cognitive Training Outcomes

  Cognitive gains will be measured according to differences between baseline and followup testing for the following tests of cognition. * Brief Visuospatial Memory Test (BVMT). This is a test of visual and spatial learning and memory. * California Verbal Learning Test (CVLT). This is a test of verbal learning and memory. * Symbol Digit Modalities Test (SDMT). This is a test of visual information processing speed. All scores for cognitive testing will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units.

  This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation)

Secondary Outcomes (3)

• Moderating role of executive function

  12 weeks, as above

• Moderating role of program adherence

  12 weeks, as above

• Impact of baseline brain connectivity on cognitive rehabilitation outcomes

  12 weeks, as above

Study Arms (1)

Cognitive Training

EXPERIMENTAL

Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.

Behavioral: Cognitive Training

Interventions

Cognitive Training BEHAVIORAL

Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.

Cognitive Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all subjects:
• males and females above age 18
• fluent in English
• education \>9 years
• Clinically definite MS diagnosis
• Expanded Disability Status Scale (EDSS) ≤ 6.5
• MS patients must be relapse-free and stable from the time of their MRI acquired for the CEG-MS study
• Willing and able to comply with the study procedures for the duration of the trial

You may not qualify if:

• history of serious medical or psychiatric illness (other than MS in the patient group) that may affect cognitive functioning
• color-blindness
• history of developmental disability
• past or current alcohol or substance dependence
• History of major depressive disorder, bipolar disorder, or psychotic disorder predating the onset of MS
• History of traumatic brain injury as defined by trauma causing loss of consciousness or transient post-traumatic or retrograde amnesia exceeding 5 min
• Other pathology related to MRI abnormalities

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Jacobs Comprehensive Multiple Sclerosis Treatment and Research Center

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 11, 2017
• Study Start: November 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: October 20, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

US (1)