Multiple SclerosisNCT07225868
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
A study testing Conscientiousness Coaching Before Cognitive Rehabilitation in people with Multiple Sclerosis, run by Universiteit Leiden at 3 sites in 3 countries.
Trial summary
People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Conscientiousness Coaching Before Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Nov 2025to 31 Dec 2028
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed relapsing remitting or secondary progressive MS diagnosis according to the McDonald 2017 criteria
- Expanded Disability Status Scale (EDSS) score < 7
- Relapse free period ≥ 3 months
- Unchanged disease modifying therapy for ≥ 2 months at time of inclusion
- Age 18-65 years
- Language Dutch, English or German for each centre respectively
Who cannot join
- High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness
- Current or prior brain trauma or neurological condition (other than MS)
- Psychiatric disorder that heavily impacts cognitive and/or daily functioning
- Medication intake and/or substance abuse that has an influence on cognitive functioning
- For Dutch subsample undergoing MRI: Contradiction for MRI
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site, 1 recruiting
- Not yet recruiting
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
Buffalo, New York, 14203
Ralph HB Benedict, Prof, 716-323-0556, benedict@buffalo.edu
Ralph HB Benedict, Prof
Netherlands1 site, 1 recruiting
- Recruiting
Health, Medical and Neuropsychology, Institute of Psychology, Faculty of Behvavioural and Social Siences, Leiden University
Leiden, 2333AK
Charlotte C Rouzée, MSc, 062 831 93 32 ext. +31, c.c.rouzee@fsw.leidenuniv.nl
Hanneke E Hulst, Prof
Switzerland1 site, 1 recruiting
- Not yet recruiting
Research Department, Reha Rheinfelden
Rheinfelden, 4310
Priska Zuber, PhD, 061 836 53 80 ext. +41, p.zuber@reha-rhf.ch
Corina Schuster-Amft, PD PhD, 061 836 53 81 ext. +41, C.Schuster@reha-rhf.ch
About this study
People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation.
Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account.
Read more
In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved.
This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).
Read the detailed description
Rationale: Cognitive impairment displays a common and impacting symptom in people with multiple sclerosis (PwMS). It has been shown that PwMS benefit from cognitive rehabilitation (CR), but group-effects are mild-to-moderate and effect sizes vary between patients, highlighting the need for including individual factors in investigating CR. It has been shown that PwMS with high conscientiousness, a personality trait that is associated with being well-organised, schema driven, achievement-striving and goal-directed show higher improvement on cognitive functions. Very recent data shows that it is possible to enhance conscientiousness in PwMS and that this increase led to more goal-directed behaviour, decreased depressive symptoms and improvements in QoL.
Objective: To investigate if conscientiousness coaching (C-Coach) before CR will enhance the treatment effects of CR, in which treatment effect is operationalised as improvement from a full comprehensive perspective of well-being of PwMS Study design: This experimental multicentre study in the Netherlands, United States and Switzerland follows a longitudinal, parallel group, controlled design with three assessment sessions including behavioural testing for both study groups and brain imaging in a subsample. Additionally, both groups will undergo either 12-weeks of C-Coach or sham training before six weeks of CR.
Study population: The study population consists of 126 PwMS aged between 18 and 65 years, of which group 1 (N= 63) will undergo C-Coach before CR and group 2 (N= 63) will undergo a sham intervention before CR.
Intervention: All interventions will be performed on mobile devices and can thus be done at home. Group 1 will undergo 12 weeks of C-Coach, which consists of a pre-session and two booster sessions with a coach to explain goals, values and the training application as well as the self-use of the smartphone application C-Coach between sessions to track goals and values. Group 2 will undergo 12 weeks of sham intervention, consisting of a pre-session and two booster sessions with a coach to discuss early life memories and the self-use of the smartphone application Daily Notes to journal about early life memories. Both groups will undergo CR after C-Coach or sham intervention, where they are asked to perform two 60-minutes training sessions per week for the duration of 6 weeks using the CR training application BrainHQ.
Main study parameters/endpoints: Main endpoint will be subjective and objective cognitive changes between baseline and post-intervention on processing speed task and improved cognitive functioning in daily life in PwMS in the intervention group compared to PwMS in the control group. As secondary endpoints, changes between baseline and post-intervention on goal attainment, meaning of life, fatigue, depression, anxiety, cognitive functioning, functional brain networks and social support in PwMS in the intervention group (C-Coach prior to CR) compared to PwMS in the control group (sham intervention prior to CR) will be studied.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of proposed interventions and procedures including MRI scan is negligible, as both can be seen as safe and non-invasive. All participants in the subsample undergoing MRI scans will undergo a detailed screening for MRI contradictions to exclude any risks. The confined space inside the MRI device for the duration of 25 minutes of the scan as well as the time investment of the participant for travel to study location and participation involves some burden for the participants. This study will offer valuable insights in the development of effective cognitive rehabilitation strategies, which will in turn positively impact patients' QoL and their ability to participate in society as they see fit.
- Conditions
- Multiple Sclerosis
- Being tested
- Conscientiousness Coaching Before Cognitive Rehabilitation, Sham Intervention Before Cognitive Rehabilitation
- Keywords
- Multiple Sclerosis, Conscientiousness, Cognitive Rehabilitation, Brain Imaging, Quality of Life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscientiousness Coaching Before Cognitive RehabilitationBehavioural
In this arm, participants complete the conscientiousness coaching before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each).
Sham Intervention Before Cognitive RehabilitationBehavioural
In this arm, participants complete the sham intervention before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each).
| Study group | Role | What they receive |
|---|---|---|
| Conscientiousness Coaching | Experimental | Not described Receives: Behavioral: Conscientiousness Coaching Before Cognitive Rehabilitation |
| Sham Intervention | Sham comparator | Not described Receives: Behavioral: Sham Intervention Before Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognitive changes between baseline and post-intervention
Objective cognitive changes between baseline and post intervention will be assessed using the Symbol Digit Modalities Test assessing information processing speed.
Measured: Between baseline and week 18.
Subjective cognitive changes between baseline and post-intervention
Subjective cognitive changes between baseline and post intervention will be assessed using the Multiple Sclerosis Instrumental Activities of Daily Living Questionnaire.
Measured: Between baseline and week 18.
Secondary outcomes (12)
Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group.
Changes on the Meaning of Life Questionnaire comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on fatigue in the intervention compared to the sham intervention group.
Changes on the Checklist of Individual Strength comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on quality of life in the intervention compared to the sham intervention group.
Changes on the 36-Item Short Form Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on psychological outcomes in the intervention compared to the sham intervention group.
Changes on the Hospital Anxiety and Depression Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between week 12 and week 18 on goal attainment in the intervention compared to the sham intervention group.
Changes on the Goal Attainment Scale comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between week 12 and week 18.
Changes between baseline and week 18 on multiple sclerosis specific cognitive functioning in the intervention compared to the sham intervention group.
Changes on the Brief International Cognitive Assessment for Multiple Sclerosis comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on cognitive flexibility in the intervention compared to the sham intervention group.
Changes on the Trail Making Test A and B comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on verbal fluency in the intervention compared to the sham intervention group.
Changes on the Controlled Oral Word Association Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 executive functions in the intervention compared to the sham intervention group.
Changes on the Stroop Test comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on functional networks in the intervention compared to the sham intervention group.
Changes on functional networks measured with resting state functional magnetic resonance imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on structural networks in the intervention compared to the sham intervention group.
Changes on Structural networks measured with Diffusion Tensor Imaging comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Changes between baseline and week 18 on social outcomes in the intervention compared to the sham intervention group.
Changes on the Medical Outcomes Study Social Support Survey comparing the intervention (C-Coach prior to CR) group with the sham intervention group.
Measured: Between baseline and week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- Reha Rheinfelden, University at Buffalo
- Responsible party
- Principal investigator, Marit Ruitenberg, Universiteit Leiden
- Investigators
- Hanneke E Hulst, Prof, Principal investigator, Leiden UniversityPriska Zuber, PhD, Principal investigator, Reha RheinfeldenRalph HB Benedict, Prof, Principal investigator, Jacobs School of Medicine and Biomedical Sciences, Neurology, University at BuffaloMarit FL Ruitenberg, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225868
- Sponsor's protocol ID
- NL86331.058.24
- Other IDs
- OZ2023-017
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS?
- ClinicalTrials.gov ID
- NCT07225868
- Acronym / sponsor ID
- NL86331.058.24
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Conscientiousness, Cognitive Rehabilitation, Brain Imaging, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- Reha Rheinfelden, University at Buffalo
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with Multiple Sclerosis (MS) often experience cognitive difficulties such as memory problems, concentration issues, and reduced processing speed. These symptoms can have a negative impact on daily functioning and overall quality of life. Previous research on cognitive rehabilitation has shown that regular training focused on memory and concentration can have positive effects on cognitive functioning, including processing speed, memory, and executive functions that support daily activities. Moreover, fMRI studies (brain scans that measure brain activity) have revealed changes in brain activation following cognitive rehabilitation.
Recently, the idea has emerged that a more personalized approach could improve treatment outcomes. Specifically, researchers have identified a link between personality traits and cognitive functioning. Since every individual is different, current cognitive rehabilitation programs often fail to take these personal differences into account.
In this project, the investigators aim to enhance the effectiveness of cognitive rehabilitation by focusing more closely on individual characteristics through an app-based training program. Participants will complete a 12-week app training prior to a 6-week cognitive rehabilitation program. The first app focuses on mindset training, supported by a coach. Afterwards, all participants will use a second app designed to train processing speed and memory. In addition to cognitive functioning, the investigators will also examine psychological, (neuro)biological, and social changes using questionnaires and fMRI. This research may provide valuable insights into how cognitive functioning and quality of life in people with MS can be improved.
This study is funded by the National MS Fund and is a collaboration between several institutions: the Department of Health, Medical and Neuropsychology at Leiden University (The Netherlands), the University at Buffalo (USA), and Reha Rheinfelden (Switzerland).
Detailed description
Rationale: Cognitive impairment displays a common and impacting symptom in people with multiple sclerosis (PwMS). It has been shown that PwMS benefit from cognitive rehabilitation (CR), but group-effects are mild-to-moderate and effect sizes vary between patients, highlighting the need for including individual factors in investigating CR. It has been shown that PwMS with high conscientiousness, a personality trait that is associated with being well-organised, schema driven, achievement-striving and goal-directed show higher improvement on cognitive functions. Very recent data shows that it is possible to enhance conscientiousness in PwMS and that this increase led to more goal-directed behaviour, decreased depressive symptoms and improvements in QoL.
Objective: To investigate if conscientiousness coaching (C-Coach) before CR will enhance the treatment effects of CR, in which treatment effect is operationalised as improvement from a full comprehensive perspective of well-being of PwMS Study design: This experimental multicentre study in the Netherlands, United States and Switzerland follows a longitudinal, parallel group, controlled design with three assessment sessions including behavioural testing for both study groups and brain imaging in a subsample. Additionally, both groups will undergo either 12-weeks of C-Coach or sham training before six weeks of CR.
Study population: The study population consists of 126 PwMS aged between 18 and 65 years, of which group 1 (N= 63) will undergo C-Coach before CR and group 2 (N= 63) will undergo a sham intervention before CR.
Intervention: All interventions will be performed on mobile devices and can thus be done at home. Group 1 will undergo 12 weeks of C-Coach, which consists of a pre-session and two booster sessions with a coach to explain goals, values and the training application as well as the self-use of the smartphone application C-Coach between sessions to track goals and values. Group 2 will undergo 12 weeks of sham intervention, consisting of a pre-session and two booster sessions with a coach to discuss early life memories and the self-use of the smartphone application Daily Notes to journal about early life memories. Both groups will undergo CR after C-Coach or sham intervention, where they are asked to perform two 60-minutes training sessions per week for the duration of 6 weeks using the CR training application BrainHQ.
Main study parameters/endpoints: Main endpoint will be subjective and objective cognitive changes between baseline and post-intervention on processing speed task and improved cognitive functioning in daily life in PwMS in the intervention group compared to PwMS in the control group. As secondary endpoints, changes between baseline and post-intervention on goal attainment, meaning of life, fatigue, depression, anxiety, cognitive functioning, functional brain networks and social support in PwMS in the intervention group (C-Coach prior to CR) compared to PwMS in the control group (sham intervention prior to CR) will be studied.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of proposed interventions and procedures including MRI scan is negligible, as both can be seen as safe and non-invasive. All participants in the subsample undergoing MRI scans will undergo a detailed screening for MRI contradictions to exclude any risks. The confined space inside the MRI device for the duration of 25 minutes of the scan as well as the time investment of the participant for travel to study location and participation involves some burden for the participants. This study will offer valuable insights in the development of effective cognitive rehabilitation strategies, which will in turn positively impact patients' QoL and their ability to participate in society as they see fit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conscientiousness Coaching | Experimental | Behavioral: Conscientiousness Coaching Before Cognitive Rehabilitation |
| Sham Intervention | Sham comparator | Behavioral: Sham Intervention Before Cognitive Rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed relapsing remitting or secondary progressive MS diagnosis according to the McDonald 2017 criteria
- Expanded Disability Status Scale (EDSS) score < 7
- Relapse free period ≥ 3 months
- Unchanged disease modifying therapy for ≥ 2 months at time of inclusion
- Age 18-65 years
Key exclusion criteria (5 listed)
- High conscientiousness, measured with a T score 65 or higher on the BFI-2 subscale for conscientiousness
- Current or prior brain trauma or neurological condition (other than MS)
- Psychiatric disorder that heavily impacts cognitive and/or daily functioning
- Medication intake and/or substance abuse that has an influence on cognitive functioning
- For Dutch subsample undergoing MRI: Contradiction for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conscientiousness Coaching Before Cognitive RehabilitationIn this arm, participants complete the conscientiousness coaching before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each). | Behavioural | Conscientiousness Coaching |
| Sham Intervention Before Cognitive RehabilitationIn this arm, participants complete the sham intervention before the cognitive rehabilitation. All participants (both arms) will receive 6 weeks of cognitive rehabilitation using BrainHQ (2 times per week, 1 hour each). | Behavioural | Sham Intervention |
Primary outcome
Objective cognitive changes between baseline and post-intervention
Time frame: Between baseline and week 18.
Objective cognitive changes between baseline and post intervention will be assessed using the Symbol Digit Modalities Test assessing information processing speed.
Subjective cognitive changes between baseline and post-intervention
Time frame: Between baseline and week 18.
Subjective cognitive changes between baseline and post intervention will be assessed using the Multiple Sclerosis Instrumental Activities of Daily Living Questionnaire.
12 secondary outcomes
Changes between baseline and week 18 on meaning of life in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on fatigue in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on quality of life in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on psychological outcomes in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between week 12 and week 18 on goal attainment in the intervention compared to the sham intervention group.
Time frame: Between week 12 and week 18.
Changes between baseline and week 18 on multiple sclerosis specific cognitive functioning in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on cognitive flexibility in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on verbal fluency in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 executive functions in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on functional networks in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on structural networks in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Changes between baseline and week 18 on social outcomes in the intervention compared to the sham intervention group.
Time frame: Between baseline and week 18.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Information about study and recruitmentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanneke E Hulst, Prof principal investigator
Leiden University
Priska Zuber, PhD principal investigator
Reha Rheinfelden
Ralph HB Benedict, Prof principal investigator
Jacobs School of Medicine and Biomedical Sciences, Neurology, University at Buffalo
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscientiousness Coaching Before Cognitive Rehabilitation in people with Multiple Sclerosis, run by Universiteit Leiden at 3 sites in 3 countries.
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 6 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: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Netherlands, Switzerland. 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. Some participants in this study may receive a placebo. 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?
Contact Charlotte C Rouzee, MSc (062 831 93 32 ext. +31, c.c.rouzee@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cognitive changes between baseline and post-intervention (time frame: Between baseline and week 18.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.