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

CompletedNot a drug-phase studyMS (type not specified)NCT03306875

What it found

No results found

We found no results in the registry or in papers.

This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Cognitive Training

What it measured

Main measures

  • Impact of Conscientiousness on Cognitive Training Outcomes

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

    Thinking and memory
  • Cognitive Training Outcomes

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

    Thinking and memory

Other measures (3)

  • Moderating role of executive function

    12 weeks, as above

    Thinking and memory
  • Moderating role of program adherence

    12 weeks, as above

    Thinking and memoryPhysical functionQuality of life (reported by participants)
  • Impact of baseline brain connectivity on cognitive rehabilitation outcomes

    12 weeks, as above

    MRI lesionsThinking and memoryNerve conduction tests

Who could take part

MS (type not specified) · 18 to 75

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Nov 2017

    2. Main results due

      Apr 2018

    3. Finished

      Oct 2018

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