Improving Cognitive Recovery in Multiple Sclerosis

NCT06877273 | Active Not Recruiting

• 1 other identifier: 348879
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Multiple Sclerosis

Keywords

Cognitive rehabilitation; cognitive training; cognitive remediation; thinking skills; randomised controlled trial; feasibility; acceptability; metacognition; cognitive remediation therapy; cognitive dysfunction; cognitive function

Outcome Measures

Primary Outcomes (15)

• Recruitment rate

  Percentage of planned sample size recruited

  Until the end of the study, estimated 15 months

• Ethnic enrolment diversity

  Percentage of sample belonging to the most common ethnicity

  Until the end of the study, estimated 15 months

• Gender enrolment diversity

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

  Until the end of the study, estimated 15 months

• Completion rate

  Percentage of participants completing week 27 measures

  Until the end of the study, estimated 15 months

• Midpoint retention

  Percentage of participants completing week 14 measures

  Until the end of the study, estimated 15 months

• Dropout

  Percentage of enrolled participants who drop out

  Until the end of the study, estimated 15 months

• Serious adverse events

  Number of serious adverse events reported

  Until the end of the study, estimated 15 months

• Manageability of adverse events

  Number of adverse events that cause the study to be halted

  Until the end of the study, estimated 15 months

• Data completeness

  Percentage outcome data complete

  Until the end of the study, estimated 15 months

• Specific measure completeness

  Percentage outcome data complete per measure

  Until the end of the study, estimated 15 months

• Operational feasibility

  Number of significant operational issues that cannot be resolved

  Until the end of the study, estimated 15 months

• Adherence: Therapy

  Percentage participants attending ≥ 70% of therapy sessions

  Until the end of the study, estimated 15 months

• Adherence: Independent sessions

  Percentage participants attending ≥ 40% of therapy sessions

  Until the end of the study, estimated 15 months

• Specific measure acceptability

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

  Until the end of the study, estimated 15 months

• Program acceptability

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

  Until the end of the study, estimated 15 months

Secondary Outcomes (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

• Brief International Cognitive Assessment for Multiple Sclerosis

  From baseline assessment at week 1 to week 27

• Digit Span

  From baseline assessment at week 1 to week 27

• Controlled Oral Word Association Test

  From baseline assessment at week 1 to week 27

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Participants 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).

Behavioral: CIRCuiTS-MS

Delayed Treatment Group

EXPERIMENTAL

Participants 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).

Behavioral: CIRCuiTS-MS

Interventions

CIRCuiTS-MS BEHAVIORAL

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.

Delayed Treatment Group; Immediate Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

King's College London

London, East of England, United Kingdom

Location

Related Links

• Website introducing the CIRCuiTS intervention

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sara Simblett, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Til Wykes, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 14, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available from the end of analysis (anticipated September 2026).
• Access Criteria: Data and supporting information will be shared upon application to the listed study team.

Locations

GB (1)