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Multiple SclerosisCIRCuiTS-MSNCT06877273

Improving Cognitive Recovery in Multiple Sclerosis

A study testing CIRCuiTS-MS in people with Multiple Sclerosis, run by King's College London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
CIRCuiTS-MS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
17 Jul 2025to 15 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • King's College London

    London, East of England

Other trials in United Kingdom

About this study

Official title: CIRCuiTS MS: Improving Cognitive Recovery in Multiple Sclerosis

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.

Read the detailed description

Objectives

The primary goal of this study is to assess the practical aspects of the research to determine whether a larger, fully-scale trial will be viable and acceptable. A feasibility decision will be reached by judging whether a suite of "Go"/"No-Go" thresholds associated with the primary outcome measures have been passed. Additionally, acceptability will be explored through qualitative analysis of participant exit interviews.

The secondary goal is to explore the potential that a larger trial will show that the program helps people with MS in meaningful ways.

Specifically, the study will examine whether the cognitive remediation program:

  1. Helps participants meet their personal goals
  2. Improves participants' cognitive function (how they think and think about thinking)
  3. Improves participants' mood (specifically feelings of anxiety and depression, which are common in people with MS)
  4. Helps reduce the severe fatigue that many people with MS experience
  5. Affects participants' ability to carry out everyday activities, such as managing tasks at home, working, and engaging in social and leisure activities.

These factors will be evaluated through assessing change in the secondary outcome measures after therapy.

Being tested
CIRCuiTS-MS
Keywords
Cognitive rehabilitation, cognitive training, cognitive remediation, thinking skills, randomised controlled trial, feasibility, acceptability, metacognition, cognitive remediation therapy, cognitive dysfunction, cognitive function
Medical subject headings
Multiple Sclerosis, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIRCuiTS-MSBehavioural

    The intervention is a blended treatment combining therapist support with carrying out tasks in CIRCuiTS™ digital cognitive remediation software. This software provides opportunities to practice a range of cognitive tasks and adaptively adjusts task difficulty. CIRCuiTS™ is much used in psychosis. Based on collaborative workshops with people with MS, participants for this trial will be asked to attend two 1-hour therapy sessions (in person or on MS Teams) and 1 hour of independent tasks each week for 12 weeks. Participants with reduced ability to operate a mouse quickly or dexterously will be offered a modified programme omitting tasks that require these abilities. The therapist will be an Assistant Psychologist trained in CIRCuiTS™ delivery and in appropriate adjustments to the needs of people with MS. They will follow a manualised template and will receive weekly supervision from an experienced clinical psychologist.

Study groups in NCT06877273
Study groupRoleWhat they receive
Immediate Treatment GroupExperimentalParticipants will start the cognitive remediation program immediately after recruitment. Outcome measures will be taken before treatment (week 1), immediately after treatment (week 14), and at 14 weeks after end of treatment (week 27).
Receives: Behavioral: CIRCuiTS-MS
Delayed Treatment GroupExperimentalParticipants will start the cognitive remediation program after being on a waitlist for 13 weeks. Outcome measures will be taken when added to the waitlist (week 1), before treatment (week 14), and immediately after treatment (week 27).
Receives: Behavioral: CIRCuiTS-MS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Percentage of planned sample size recruited

    Measured: Until the end of the study, estimated 15 months

  2. Ethnic enrolment diversity

    Percentage of sample belonging to the most common ethnicity

    Measured: Until the end of the study, estimated 15 months

  3. Gender enrolment diversity

    Difference in the percentages of recruited participants identifying as male and female

    Measured: Until the end of the study, estimated 15 months

  4. Completion rate

    Percentage of participants completing week 27 measures

    Measured: Until the end of the study, estimated 15 months

  5. Midpoint retention

    Percentage of participants completing week 14 measures

    Measured: Until the end of the study, estimated 15 months

  6. Dropout

    Percentage of enrolled participants who drop out

    Measured: Until the end of the study, estimated 15 months

  7. Serious adverse events

    Number of serious adverse events reported

    Measured: Until the end of the study, estimated 15 months

  8. Manageability of adverse events

    Number of adverse events that cause the study to be halted

    Measured: Until the end of the study, estimated 15 months

  9. Data completeness

    Percentage outcome data complete

    Measured: Until the end of the study, estimated 15 months

  10. Specific measure completeness

    Percentage outcome data complete per measure

    Measured: Until the end of the study, estimated 15 months

  11. Operational feasibility

    Number of significant operational issues that cannot be resolved

    Measured: Until the end of the study, estimated 15 months

  12. Adherence: Therapy

    Percentage participants attending ≥ 70% of therapy sessions

    Measured: Until the end of the study, estimated 15 months

  13. Adherence: Independent sessions

    Percentage participants attending ≥ 40% of therapy sessions

    Measured: Until the end of the study, estimated 15 months

  14. Specific measure acceptability

    Percentage of participants who provide answers to demographic/medical background questions

    Measured: Until the end of the study, estimated 15 months

  15. Program acceptability

    Mean score on the general acceptability item of the Theoretical Framework of Acceptability Questionnaire

    Measured: Until the end of the study, estimated 15 months

Secondary outcomes (9)
  1. Goal Attainment Scale

    A personalised measure used to assess the extent to which patient-specific goals are achieved during therapy. Goals are collaboratively set between the therapist and patient, and the level of attainment is rated on a scale typically ranging from -2 (much less than expected outcome) to +2 (much more than expected outcome).

    Measured: From goal setting in week 1 to week 27

  2. Measure of Insight into Cognition

    A self-report questionnaire designed to assess an individual's awareness and understanding of their cognitive abilities and deficits. It is particularly useful in clinical settings where cognitive impairments are common, such as in MS. The MIC consists of a series of statements that participants rate based on their perception of their cognitive functions. Each item is rated on a Likert scale, ranging from 1 to 5, from strongly agree to strongly disagree. The total score is the sum or average of the scores for the items. Higher scores indicate greater insight into one's cognitive abilities and deficits.

    Measured: From baseline assessment at week 1 to week 27

  3. Brief International Cognitive Assessment for Multiple Sclerosis

    Designed for rapid assessment of neuropsychological abilities commonly affected in MS. Comprises:

    The Symbol Digit Modalities Test, measuring processing speed and attention. The participant is asked to orally identify the digits associated with test symbols within a key. It is scored on the number of digits correctly identified within 90 seconds.

    Tasks 1-3 of the Brief Visuospatial Memory Test, measuring immediate visual recall. The participant inspects an array of 6 abstract geometric figures during three 10-second learning trials and then draws the array from memory. Higher scores are awarded for more accurate figure reproduction and positioning.

    Tasks 1-5 of the California Verbal Learning Test-Second Edition, measuring verbal working memory. The rater reads a 16-item word list aloud five times to the participant, who is then required to recall as many as possible.

    Measured: From baseline assessment at week 1 to week 27

  4. Digit Span

    This subtest from the Wechsler Adult Intelligence Scale Version 4 will be administered because it is a widely used measure of attention and working memory that does not show strong correlations with the California Verbal Learning Test. The participants is required to repeat sequences of digits, proceeding to longer sequences if correct, then repeat sequences backwards and in numerical order.

    Measured: From baseline assessment at week 1 to week 27

  5. Controlled Oral Word Association Test

    A widely used neuropsychological assessment tool designed to measure verbal fluency, a component of executive function. It assesses the ability to generate words according to specific phonemic and semantic criteria within a limited time frame. The COWAT is commonly used in the diagnosis and evaluation of various neurological and psychiatric conditions. To measure phonemic fluency, participants are asked to produce as many words as possible that begin with a specific letter (usually F, A, and S) within 60 seconds for each letter. To measure semantic fluency, participants are asked to produce as many words as possible within a category (e.g., animals) within 60 seconds. The number of correct words generated in each category (phonemic and semantic) is counted. Repetitions, proper nouns, and variations of the same word are not included in the score. Errors will also be analysed, such as repetitions or rule violations, providing additional insights into cognitive function.

    Measured: From baseline assessment at week 1 to week 27

  6. Patient Health Questionnaire-9

    A widely used self-administered tool for screening, diagnosing, monitoring, and measuring the severity of depression. It is based on the diagnostic criteria for major depressive disorder outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). The PHQ-9 consists of 9 items, each corresponding to one of the DSM-IV criteria for depression. Each item is rated on a 4-point Likert scale based on the frequency of symptoms over the past two weeks. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.

    Measured: From baseline assessment at week 1 to week 27

  7. Generalised Anxiety Disorder Scale

    A brief, self-report screening tool commonly used in clinical and research settings to assess the severity of generalised anxiety disorder (GAD) symptoms. The GAD-7 provides an efficient way to identify GAD symptoms and track their severity over time. The GAD-7 contains 7 questions that evaluate the frequency of core anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.

    Measured: From baseline assessment at week 1 to week 27

  8. Fatigue Severity Scale

    A self-report questionnaire designed to assess the impact of fatigue on a person's daily life. It is widely used in clinical and research settings to evaluate fatigue in various conditions, including multiple sclerosis (MS). The FSS consists of 9 statements related to the severity and impact of fatigue. Each item is rated on a 7-point Likert scale. The total score is the average of the scores for the 9 items, resulting in a score range from 1 to 7. Higher scores indicate greater fatigue severity and impact.

    Measured: From baseline assessment at week 1 to week 27

  9. Work and Social Adjustment Scale

    A self-report questionnaire designed to assess the impact of a person's mental health on their daily functioning. It is widely used in both clinical and research settings to gauge the extent to which psychological problems interfere with a person's ability to perform various life roles. The WSAS consists of 5 items, corresponding to five domains of daily functioning: work, home management, social leisure activities, private leisure activities, and family and relationships. Each item is rated on an 8-point Likert scale from 0 (not at all impaired) to 8 (severely impaired). The total score is the sum of the ratings for the five items, resulting in a score range from 0 to 40. Higher scores indicate greater impairment. A total score of 20 or above suggests significant functional impairment.

    Measured: From baseline assessment at week 1 to week 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start17 Jul 2025
  3. Primary completion15 Sep 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be randomly assigned to one of two groups: 1. Immediate Treatment Group: Participants will start the cognitive remediation program immediately. 2. Delayed Treatment Group: Participants will be placed on a waitlist and receive the program after 14 weeks
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877273
Sponsor's protocol ID
348879
Acronym
CIRCuiTS-MS
Status last verified
Apr 2026
First submitted
7 Mar 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified text-based participant data and a data dictionary describing the data types collected will be provided.

Publications

  • Thomas RJ, Cella M, Brex PA, Silber E, Fifield K, Burke P, Summers M, Simblett S, Wykes T. Co-development of a protocol for a randomised controlled feasibility trial of CIRCuiTS cognitive remediation therapy for people with multiple sclerosis. Pilot Feasibility Stud. 2026 Jun 20. doi: 10.1186/s40814-026-01862-2. Online ahead of print.

    PubMed 42321924

Questions about this trial

What is this clinical trial studying?

A study testing CIRCuiTS-MS in people with Multiple Sclerosis, run by King's College London at 1 site in United Kingdom.

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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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 Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Recruitment rate (time frame: Until the end of the study, estimated 15 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06877273, which also lists 1 linked publication.

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 17 Apr 2026.

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