Multiple SclerosisNCT02301260
Speed of Processing Training to Improve Cognition in Multiple Sclerosis
A study testing Speed of Processing Training (SPT) in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Speed of Processing Training (SPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English as a primary language
- diagnosis of Multiple Sclerosis
- processing speed impairment (based on evaluation)
Who cannot join
- most recent exacerbation within one month
- currently taking steroids or benzodiazepines
- history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
- significant alcohol or drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life. This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.
Read the detailed description
This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS. This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures. In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other. This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.
- Conditions
- Multiple Sclerosis
- Being tested
- Speed of Processing Training (SPT), Placebo Control
- Keywords
- Processing Speed, Intervention, Multiple Sclerosis, Cognition
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed of Processing Training (SPT)Behavioural
Placebo ControlBehavioural
Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
| Study group | Role | What they receive |
|---|---|---|
| Speed of Processing Training (SPT) | Experimental | SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). Receives: Behavioral: Speed of Processing Training (SPT) |
| Placebo control group | Placebo comparator | Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions) Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on standardized tests of processing speed
Measured: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Secondary outcomes (3)
Change in scores on self-report of emotional functioning, measured via questionnaire
Self-report questionnaires and objective measures of everyday performance will be used to determine whether there have been changes across the three time points.
Measured: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Change in scores on self-report of everyday functioning, measured via questionnaire
Measured: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
Change in scores on self-report of quality of life, measured via questionnaire
Measured: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Nancy Chiaravalloti, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301260
- Sponsor's protocol ID
- RG 4997A5/1
- Status last verified
- Feb 2020
- First submitted
- 23 Apr 2014
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Goverover Y, Costa S, DeLuca J, Chiaravalloti N. The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. Arch Phys Med Rehabil. 2023 Jun;104(6):925-931. doi: 10.1016/j.apmr.2023.01.017. Epub 2023 Feb 8.
PubMed 36758712
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed of Processing Training to Improve Cognition in Multiple Sclerosis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02301260
- Acronym / sponsor ID
- RG 4997A5/1
- Conditions
- Multiple Sclerosis
- Keywords
- Processing Speed, Intervention, Multiple Sclerosis, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Apr 2014
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 25 Nov 2014 (estimated)
- 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.
The purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (MS) population. The study is designed to study how well this technique can help people with MS increase their processing speed and their ability to function better in everyday life. This treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.
Detailed description
This study is a double-blind, placebo-control randomized clinical trial examining the efficacy of Speed of Processing Training (SPT) for improving processing speed (PS) deficits in persons with Multiple Sclerosis (MS). Slowed PS is one of the most common deficits in individuals with MS and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. Despite these findings, few studies have attempted to remediate PS deficits in order to improve the everyday functioning of individuals with MS. This study is designed to (1) apply a treatment protocol for PS impairments well-validated in an aging population to individuals with MS with objectively observable deficits in PS and document its efficacy on standard neuropsychological outcome measures. In addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the Timed Activities of Daily Living; TIADL), as well as additional questionnaires to be completed by both the participant and a significant other. This study is also designed to (3) examine the influence of degree of PS impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.
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 |
|---|---|---|
| Speed of Processing Training (SPT) | Experimental | Behavioral: Speed of Processing Training (SPT)SPT will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). |
| Placebo control group | Placebo comparator | Behavioral: Placebo ControlPlacebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 sessions) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English as a primary language
- diagnosis of Multiple Sclerosis
- processing speed impairment (based on evaluation)
Key exclusion criteria (4 listed)
- most recent exacerbation within one month
- currently taking steroids or benzodiazepines
- history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
- significant alcohol or drug abuse history
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 |
|---|---|---|
| Speed of Processing Training (SPT) | Behavioural | Speed of Processing Training (SPT) |
| Placebo ControlPlacebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). | Behavioural | Placebo control group |
Primary outcome
Change in scores on standardized tests of processing speed
Time frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
3 secondary outcomes
Change in scores on self-report of emotional functioning, measured via questionnaire
Time frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Change in scores on self-report of everyday functioning, measured via questionnaire
Time frame: Three points in time: pre-treatment, immediately following treatment and 6 months after treatment is completed
Change in scores on self-report of quality of life, measured via questionnaire
Time frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 36758712Goverover Y, Costa S, DeLuca J, Chiaravalloti N. The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. Arch Phys Med Rehabil. 2023 Jun;104(6):925-931. doi: 10.1016/j.apmr.2023.01.017. Epub 2023 Feb 8.
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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. This study is not recruiting at the moment.
Nancy Chiaravalloti, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of Processing Training (SPT) 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in scores on standardized tests of processing speed (time frame: Three points in time: baseline (week1), immediately following treatment (week 7) and 6 months after treatment is completed). 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 NCT02301260, 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 20 Feb 2020.