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

November 21, 2018 updated by: Ralph H.B. Benedict, State University of New York at Buffalo

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. 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. a] The investigator expects that individual differences in structural and functional connectome disturbances will in part explain differences in participant responses to cognitive rehabilitation.

This study will also serve to supplement the sample of participants for the current IRB approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study of cardiovascular, environmental and genetic risk factors for disease progression in patients with multiple sclerosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The participant will be asked to make a total of two (2) visits, approximately 90 days apart. Each visit will involve: neuro-performance testing, and self-report questionnaires. Each study visit is expected to take approximately 1-2 hours. Between the two visits, the participant will be asked to complete a 12 week, computer-based cognitive training program. This includes 1 hour of training each day for 5 days each week.

On Visit 1, the participants will undergo a full battery of neuro-performance tasks including tests and questionnaires that will measure their memory, thinking speed, fatigue, and personality. This visit is expected to take approximately 1-2 hours. The participants will be also asked to have a close friend or family member to complete similar surveys. A self-addressed envelope containing these questionnaires will be provided to take home with them. The participant will need to pass it onto a close friend or family member to be completed and mailed back.

In addition, the participant will be asked to take part in the 12 week computerized cognitive training program. This can be done at home, or anywhere the participant has access to a computer and internet. This cognitive training has been shown to improve cognitive performance in people with multiple sclerosis. The training involves a variety of interactive exercises which adapt to their abilities. The participants will need complete 1 hour of training each day, for 5 days each week.

At 90 days, the participant will return for the 1-2 hours' follow-up visit where they will complete the same cognitive testing and questionnaires which they had completed during visit 1.

All study visits will take place at Buffalo General Hospital. All of the procedures described above will be performed by a trained member of the research team as part of the research study.

If an individual is ineligible for participation, their screening information will be discarded (i.e., shredded). If participants are deemed eligible (either in person or over the phone), they will be scheduled to come in to the hospital for neuropsychological testing. Written consent will be obtained prior to administration of tests. As part of the consent process, participants will be asked for permission to use any data collected as part of the screening process as well.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Jacobs Comprehensive Multiple Sclerosis Treatment and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

For all subjects:

  • males and females above age 18
  • fluent in English
  • education >9 years

Additional inclusion criteria for MS patients are as follows:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive Training
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
Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact of Conscientiousness on Cognitive Training Outcomes
Time Frame: This outcome will be measured according to changes from baseline cognition to follow-up measures, 12 weeks later (following cognitive rehabilitation)

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

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moderating role of executive function
Time Frame: 12 weeks, as above

The investigator will assess whether baseline scores of executive function moderate the impact of Conscientiousness on cognitive training.

Executive function will be reported according to scores on the following tests.

  • Delis-Kaplan Executive Function System (D-KEFS) Tower Test.
  • D-KEFS Sorting Test.
  • Elithorn Perceptual Maze Test (EPMT). All scores for executive function will be converted to age-corrected t-scores for final analysis. These are therefore standardized values without units.
12 weeks, as above
Moderating role of program adherence
Time Frame: 12 weeks, as above
The investigator will assess whether daily program adherence is a moderates the impact of Conscientiousness on cognitive training. Daily program adherence will be measured according to days and hours spent on cognitive training exercises.
12 weeks, as above
Impact of baseline brain connectivity on cognitive rehabilitation outcomes
Time Frame: 12 weeks, as above

The investigator will assess whether individual differences in structural and functional connectome disturbances in part explain differences in participant responses to cognitive rehabilitation.

In order to address outcome number 5, white matter tract disruption will be characterized in order to determine how structural networks are impacted by white matter lesions. Tract disruption will be reported as the proportion of tracts normally connecting pairs of gray matter brain regions which are disrupted by lesions. These will therefore be reported as percent values.
12 weeks, as above

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001899

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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