Multiple SclerosisNCT03306875
Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis
A study testing Cognitive Training in people with Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 20 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacobs Comprehensive Multiple Sclerosis Treatment and Research Center
Buffalo, New York, 14203
About this study
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:
Read more
[1a] The investigator expects that individuals with low baseline Conscientiousness will experience a lower magnitude of overall cognitive improvement following rehabilitation
- 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
- 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive Training
- Keywords
- multiple sclerosis, cognitive training, telerehabilitation, personality, Conscientiousness, predict
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 12 weeks, as above
Moderating role of program adherence
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.
Measured: 12 weeks, as above
Impact of baseline brain connectivity on cognitive rehabilitation outcomes
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.
Measured: 12 weeks, as above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Apr 2018
- Study completion20 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph H.B. Benedict, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306875
- Sponsor's protocol ID
- STUDY00001899
- Status last verified
- Nov 2018
- First submitted
- 27 Sep 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03306875
- Acronym / sponsor ID
- STUDY00001899
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, cognitive training, telerehabilitation, personality, Conscientiousness, predict
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingIndividuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- males and females above age 18
- fluent in English
- education >9 years
- Clinically definite MS diagnosis
- Expanded Disability Status Scale (EDSS) ≤ 6.5
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingIndividuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function. | Behavioural | Cognitive Training |
Primary outcome
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.
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.
3 secondary outcomes
Moderating role of executive function
Time frame: 12 weeks, as above
Moderating role of program adherence
Time frame: 12 weeks, as above
Impact of baseline brain connectivity on cognitive rehabilitation outcomes
Time frame: 12 weeks, as above
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Multiple Sclerosis, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.