CIRCuiTS MS: Improving Cognitive Recovery in Multiple Sclerosis

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT06877273

What it found

Still running

No result yet.

What was tested

Treatment tested

  • CIRCuiTS-MS

What it measured

Main measures

  • Recruitment rate

    Until the end of the study, estimated 15 months

    Feasibility
  • Ethnic enrolment diversity

    Until the end of the study, estimated 15 months

  • Gender enrolment diversity

    Until the end of the study, estimated 15 months

  • Completion rate

    Until the end of the study, estimated 15 months

  • Midpoint retention

    Until the end of the study, estimated 15 months

    Feasibility
  • Dropout

    Until the end of the study, estimated 15 months

  • Serious adverse events

    Until the end of the study, estimated 15 months

    Safety
  • Manageability of adverse events

    Until the end of the study, estimated 15 months

    Safety
  • Data completeness

    Until the end of the study, estimated 15 months

  • Specific measure completeness

    Until the end of the study, estimated 15 months

  • Operational feasibility

    Until the end of the study, estimated 15 months

    Feasibility
  • Adherence: Therapy

    Until the end of the study, estimated 15 months

    Quality of life (reported by participants)
  • Adherence: Independent sessions

    Until the end of the study, estimated 15 months

    Quality of life (reported by participants)
  • Specific measure acceptability

    Until the end of the study, estimated 15 months

    Feasibility
  • Program acceptability

    Until the end of the study, estimated 15 months

    Feasibility

Other measures (9)

  • Goal Attainment Scale

    From goal setting in week 1 to week 27

  • Measure of Insight into Cognition

    From baseline assessment at week 1 to week 27

    Thinking and memory
  • Brief International Cognitive Assessment for Multiple Sclerosis

    From baseline assessment at week 1 to week 27

    Thinking and memory
  • Digit Span

    From baseline assessment at week 1 to week 27

    Thinking and memory
  • Controlled Oral Word Association Test

    From baseline assessment at week 1 to week 27

    Thinking and memory
  • Patient Health Questionnaire-9

    From baseline assessment at week 1 to week 27

    Mood and sleep
  • Generalised Anxiety Disorder Scale

    From baseline assessment at week 1 to week 27

    Mood and sleep
  • Fatigue Severity Scale

    From baseline assessment at week 1 to week 27

    Fatigue
  • Work and Social Adjustment Scale

    From baseline assessment at week 1 to week 27

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Participants must have a confirmed diagnosis of Multiple Sclerosis (MS), as verified by a healthcare provider. * Participants should be in a relatively stable phase of their condition, not experiencing a severe relapse or acute health crisis at the time of the study. * Participants must have sufficient cognitive abilities to engage in therapy sessions, meaning they can follow instructions and perform the cognitive tasks required during the remediation program. * Participants must be able to effectively communicate in English, both verbally and in writing, to interact with therapists and complete assessments. * Participants must be adults aged 18 years or older. * Participants should have personal experience with cognitive challenges related to MS, such as problems with memory, attention, or problem-solving. * Participants must be willing and able to commit to attending all therapy sessions over the 12-week period, as well as attending assessments and completing any required homework or independent sessions. * Participants must provide informed consent, demonstrating that they understand the purpose of the therapy trial and are willing to engage in the course of cognitive remediation. * Participants must have access to a computer (laptop or desktop) for at least one hour per week during the treatment period (12 weeks).

Exclusion criteria

* Individuals who are currently receiving cognitive remediation or a similar intervention. * Individuals with high levels of depression, indicated by a score greater than 9 on the Patient Health Questionnaire-9 (PHQ-9). * Individuals with active suicidal ideation, indicated by a score greater than 0 on question 9 of the PHQ-9. * Individuals with a diagnosis of a psychotic disorder or bipolar disorder. * Physical disabilities that severely limit the individual's ability to attend therapy sessions or engage with the cognitive tasks (whether in-person or online) may lead to exclusion if suitable adaptations cannot be made.

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 find out whether an adapted version of an existing cognitive rehabilitation program, CIRCuiTS (https://www.circuitstherapyinfo.com), can be used to improve everyday thinking skills for people with Multiple Sclerosis (MS). People living with MS have worked with the study's researchers to adapt CIRCuiTS to meet their needs. They shared the thinking challenges they experience and suggested changes to the program's content and how it is delivered. This study will test whether this adapted version can be delivered practically to people with MS in a trial setting and explore its potential benefits. The findings will help plan a larger trial testing how effective CIRCuiTS is in helping people with MS. Twenty-four people with MS will take part in this pilot trial. Each person will be randomly assigned to start the program either right away or after a 13-week wait. The therapy program involves up to 36 hours of therapist-led and independent sessions over 12 weeks in which the participant builds thinking skills through developing personal strategies for carrying out digital versions of tasks they find challenging. The practicality of delivering the program to people with MS will be judged based on whether problems arise in the trial, such as not being able to recruit enough people or participants not liking it. To explore its potential benefits, the study will check for improvements in progress toward personal goals, thinking abilities, emotional well-being, chronic tiredness, and daily living skills after the therapy. If delivering CIRCuiTS to people with MS is found to be both practical and acceptable to participants, the findings of this trial will be used to design a larger-scale trial of its effectiveness. Ultimately, the goal of this project is to improve the quality of life of people living with cognitive difficulties related to MS.

Papers

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History

    1. Started

      Jul 2025

    2. Main results due

      Sept 2026

    3. Finished

      Sept 2026

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