Multiple SclerosisNCT06608797
Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community
A study testing Learning and memory training in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Learning and memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 31 Dec 2025
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English as primary language
- Diagnosis of multiple sclerosis
Who cannot join
- Most recent exacerbation within one month
- Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
- Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
- Poor Visual Acuity (corrected vision in worse eye \< 20/60), diplopia, or nystagmus
- Inability to understand directions and following one, two, and three step commands
- Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Silvana M Lopes Costa, PhD, 9733248458, scosta@kesslerfoundation.org
Emily Fernandez, 973-323-3759, efernandez@kesslerfoundation.org
About this study
Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Learning and memory training, Sham Comparator
- Keywords
- learning, memory, cognitive training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning and memory trainingBehavioural
The experimental group will receive memory retraining exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 training sessions).
Sham ComparatorBehavioural
The sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions).
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Computer based cognitive training delivered remotely via Zoom Health Receives: Behavioral: Learning and memory training |
| sham comparator | Sham comparator | The sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions). Receives: Behavioral: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Learning Verbal Test III
Measured: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)
Secondary outcomes (1)
Ecological Memory Simulations
Measured: Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start30 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvana Costa, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608797
- Sponsor's protocol ID
- E-1259-24
- Status last verified
- Feb 2025
- First submitted
- 13 Sep 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is pilot data for potential future funding
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community
- ClinicalTrials.gov ID
- NCT06608797
- Acronym / sponsor ID
- E-1259-24
- Conditions
- Multiple Sclerosis
- Keywords
- learning, memory, cognitive training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Learning and memory trainingComputer based cognitive training delivered remotely via Zoom Health |
| sham comparator | Sham comparator | Behavioral: Sham ComparatorThe sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English as primary language
- Diagnosis of multiple sclerosis
Key exclusion criteria (6 listed)
- Most recent exacerbation within one month
- Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
- Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
- Poor Visual Acuity (corrected vision in worse eye \< 20/60), diplopia, or nystagmus
- Inability to understand directions and following one, two, and three step commands
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 |
|---|---|---|
| Learning and memory trainingThe experimental group will receive memory retraining exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 training sessions). | Behavioural | Training |
| Sham ComparatorThe sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions). | Behavioural | sham comparator |
Primary outcome
California Learning Verbal Test III
Time frame: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)
1 secondary outcome
Ecological Memory Simulations
Time frame: Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)
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 21 Feb 2025.
- Individual participant dataSharing planned: No. This is pilot data for potential future funding
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning and memory training in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
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 2 inclusion and 6 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 21 Feb 2025. 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 States. 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 Silvana L Costa Research Scientist, PhD (973 324 8458, scosta@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
California Learning Verbal Test III (time frame: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)). 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 21 Feb 2025.