NCT06877273

Improving Cognitive Recovery in Multiple Sclerosis

CIRCuiTS MS: Improving Cognitive Recovery in Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	CIRCuiTS-MS	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.

Timeline

• Start date: 2025-07-17
• Primary completion: 2026-09-15
• Completion: 2026-09-15
• First posted: 2025-03-14
• Last updated: 2026-04-17

Locations

1 site across 1 country: United Kingdom