Multiple SclerosisSPTMSNCT01838824
Applying Speed of Processing Training to Individuals With Multiple Sclerosis
A study testing Speed of Processing Training in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. 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?
- Speed of Processing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusions:
- diagnosis of Multiple Sclerosis
- fluent in English
- processing speed impairment (based on evaluation).
Exclusions:
- currently taking steroids and /or benzodiazepines
- prior stroke or neurological disease
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
- significant alcohol or drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with MS with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with MS utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the MS population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in MS could have a profound impact on the population and society as a whole.
- Conditions
- Multiple Sclerosis
- Being tested
- Speed of Processing Training
- 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 TrainingBehavioural
SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself.
| Study group | Role | What they receive |
|---|---|---|
| Speed of Processing Training - Group 1 | Experimental | Group 1 will receive speed of processing training immediately following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment. Receives: Behavioral: Speed of Processing Training |
| Speed of Processing Training - Group 2 | Experimental | Group 2 will receive speed of processing training 6 weeks following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment. Receives: Behavioral: Speed of Processing Training |
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
Standardized neuropsychological tests which be used will be used to determine whether there has been a change in speed of processing.
Measured: Three points in time: Baseline (week 1), immediately following treatment (Group 1 - week 7, Group 2 - week 13), long-term follow-up (Group 1 - week 13, Group 2 - Week 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2020
- Study completionDec 2021
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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 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
- NCT01838824
- Sponsor's protocol ID
- RG 4607-A-3
- Acronym
- SPTMS
- Status last verified
- Mar 2022
- First submitted
- 11 May 2012
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Speed of Processing Training (SPT) to Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01838824
- Acronym / sponsor ID
- SPTMS / RG 4607-A-3
- Conditions
- Multiple Sclerosis
- Keywords
- Processing Speed, Intervention, Multiple Sclerosis, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Nov 2011
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Apr 2013 (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.
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with MS with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with MS utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the MS population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in MS could have a profound impact on the population and society as a whole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speed of Processing Training - Group 1 | Experimental | Behavioral: Speed of Processing TrainingGroup 1 will receive speed of processing training immediately following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment. |
| Speed of Processing Training - Group 2 | Experimental | Behavioral: Speed of Processing TrainingGroup 2 will receive speed of processing training 6 weeks following baseline testing. They will have an evaluation immediately following treatment and a long-term follow-up 6 weeks after finishing treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 TrainingSPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. | Behavioural | Speed of Processing Training - Group 1, Speed of Processing Training - Group 2 |
Primary outcome
Change in scores on standardized tests of processing speed
Time frame: Three points in time: Baseline (week 1), immediately following treatment (Group 1 - week 7, Group 2 - week 13), long-term follow-up (Group 1 - week 13, Group 2 - Week 19)
Standardized neuropsychological tests which be used will be used to determine whether there has been a change in speed of processing.
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 15 Mar 2022.
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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 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?
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 15 Mar 2022. 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. 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 (week 1), immediately following treatment (Group 1 - week 7, Group 2 - week 13), long-term follow-up (Group 1 - week 13, Group 2 - Week 19)). 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 15 Mar 2022.