Multiple SclerosisNCT02032589
Testing the Efficacy of Self-Generation Treatment Protocol
A study testing Self-generation treatment in people with Multiple Sclerosis, run by Kessler Foundation at 1 site in United States.
Trial summary
Past research has shown that items self-generated by an individual, such as words or concepts, are remembered better than items that are simply read or heard. The current study seeks to demonstrate the effectiveness of using the principles of the generation effect in a treatment intervention to improve memory and… 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?
- Self-generation treatment
- 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
- Jan 2014to Dec 2014
- 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
Who may be able to join
- Diagnosis of Multiple sclerosis
Who cannot join
- Diagnosis of other neurological conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052
Nancy B Moore, MA, 973-324-8450, nbmoore@kesslerfoundation.org
John DeLuca, PhD
About this study
Official title: Exploring the Effects of a Memory Intervention on Memory and Everyday Life Activities With Persons With MS
Past research has shown that items self-generated by an individual, such as words or concepts, are remembered better than items that are simply read or heard. The current study seeks to demonstrate the effectiveness of using the principles of the generation effect in a treatment intervention to improve memory and functional performance in individuals with Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is to conduct an experimental investigation on the effects of a self-generation strategy treatment, embedded within practice of various activities ranging from laboratory tasks (e.g. words and concepts) to functional tasks (e.g. activities of daily living). The treatment to be tested is geared toward helping patients selfdiscover their own strengths and abilities while using self-generation to be able to utilize it independently in everyday life situations.
Design: The proposed pilot study is a randomized clinical trial. Participants: Participants will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate memory impairments. Half of the participants will receive the self-generation training while learning different types of tasks (experimental group) and half of the participants (control group) will be asked to learn the same information but will receive a conventional practice (e.g. repetitions).
Expected results: We expect that participants undergoing the self-generation-training intervention will show better memory performance, functional performance, quality of life, and satisfaction with treatment and life compared to participants in the control condition.
Read the detailed description
If self- generation can be successfully adapted and applied to a treatment program for individuals with MS, it has the potential to improve their rehabilitation and treatment by facilitating new learning and memory. In addition, if treatment and rehabilitation are successful and productive, it is expected that the application of self-generation strategy to improve learning/ relearning will help to improve the ability of individuals with MS to maintain their current lifestyles at home, work, and within the community. We expect that persons with MS who complete the proposed treatment will acquire the trained strategy, recognize the everyday situations in which the trained strategy could be applied and then map and adapt the trained strategy to real-world situations.
Fourty participants with clinically definite MS and objectively documented impairment in verbal new learning will be included in the study. Participants will be randomly assigned to either the treatment group (n=20) or the control group (n=20). Participants will be enrolled only following an informed consent procedure, with the expectation of being able to participate for the full duration of the study (6 treatment sessions and two assessment sessions). All participants enrolled in the study will undergo pre and post treatment assessment to assess their levels of cognitive, emotional, and functional performance. Treatment for both experimental and control groups will consist of 6 individualized treatment sessions, 2 x per week for 3 weeks. Each session will last for approximately 45 minutes, and will include various memory tasks that will range from learning list of words to learning tasks related to everyday life. Participants in the control group will only be asked to perform the same memory tasks as the treatment group. The treatment for the experimental group will couple self-generated learning with awareness-training techniques, which are geared toward helping patients self-discover their performance strengths and limitations through integration of direct and personal experiences. Personal experience will be gained by practicing various memory tasks using self-generation strategy. This proposed self-generation program is expected to increase memory, task specific awareness and functional performance; ultimately improving quality of life and self-regulation.
- Conditions
- Multiple Sclerosis
- Being tested
- Self-generation treatment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-generation treatmentBehavioural
self-generation treatment is a cognitive rehabilitation strategy aimed to improve memory. The self-generation strategy treatment, embedded within practice of various activities will consists of six individualized intervention sessions administered over 2-3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Self-generation treatment | Experimental | self-generation strategy treatment, embedded within practice of various activities Receives: Behavioral: Self-generation treatment |
| memory training | Placebo comparator | Treatment consists on traditional memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Assessment
Measured: Baseline assessment, and Week 3
Secondary outcomes (1)
Assessment of Global Functioning
Measured: Baseline and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Yael Goverover, Kessler Foundation
- Investigators
- Yael Goverover, PhD, Principal investigator, Kessler FoundationJohn DeLuca, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032589
- Sponsor's protocol ID
- 698-11 GE
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Goverover Y, Chiaravalloti N, Genova H, DeLuca J. A randomized controlled trial to treat impaired learning and memory in multiple sclerosis: The self-GEN trial. Mult Scler. 2018 Jul;24(8):1096-1104. doi: 10.1177/1352458517709955. Epub 2017 May 9.
PubMed 28485659
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of a Memory Intervention on Memory and Everyday Life Activities With Persons With MS
- ClinicalTrials.gov ID
- NCT02032589
- Acronym / sponsor ID
- 698-11 GE
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Jan 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.
Past research has shown that items self-generated by an individual, such as words or concepts, are remembered better than items that are simply read or heard. The current study seeks to demonstrate the effectiveness of using the principles of the generation effect in a treatment intervention to improve memory and functional performance in individuals with Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is to conduct an experimental investigation on the effects of a self-generation strategy treatment, embedded within practice of various activities ranging from laboratory tasks (e.g. words and concepts) to functional tasks (e.g. activities of daily living). The treatment to be tested is geared toward helping patients selfdiscover their own strengths and abilities while using self-generation to be able to utilize it independently in everyday life situations.
Design: The proposed pilot study is a randomized clinical trial. Participants: Participants will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate memory impairments. Half of the participants will receive the self-generation training while learning different types of tasks (experimental group) and half of the participants (control group) will be asked to learn the same information but will receive a conventional practice (e.g. repetitions).
Expected results: We expect that participants undergoing the self-generation-training intervention will show better memory performance, functional performance, quality of life, and satisfaction with treatment and life compared to participants in the control condition.
Detailed description
If self- generation can be successfully adapted and applied to a treatment program for individuals with MS, it has the potential to improve their rehabilitation and treatment by facilitating new learning and memory. In addition, if treatment and rehabilitation are successful and productive, it is expected that the application of self-generation strategy to improve learning/ relearning will help to improve the ability of individuals with MS to maintain their current lifestyles at home, work, and within the community. We expect that persons with MS who complete the proposed treatment will acquire the trained strategy, recognize the everyday situations in which the trained strategy could be applied and then map and adapt the trained strategy to real-world situations.
Fourty participants with clinically definite MS and objectively documented impairment in verbal new learning will be included in the study. Participants will be randomly assigned to either the treatment group (n=20) or the control group (n=20). Participants will be enrolled only following an informed consent procedure, with the expectation of being able to participate for the full duration of the study (6 treatment sessions and two assessment sessions). All participants enrolled in the study will undergo pre and post treatment assessment to assess their levels of cognitive, emotional, and functional performance. Treatment for both experimental and control groups will consist of 6 individualized treatment sessions, 2 x per week for 3 weeks. Each session will last for approximately 45 minutes, and will include various memory tasks that will range from learning list of words to learning tasks related to everyday life. Participants in the control group will only be asked to perform the same memory tasks as the treatment group. The treatment for the experimental group will couple self-generated learning with awareness-training techniques, which are geared toward helping patients self-discover their performance strengths and limitations through integration of direct and personal experiences. Personal experience will be gained by practicing various memory tasks using self-generation strategy. This proposed self-generation program is expected to increase memory, task specific awareness and functional performance; ultimately improving quality of life and self-regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-generation treatment | Experimental | Behavioral: Self-generation treatmentself-generation strategy treatment, embedded within practice of various activities |
| memory training | Placebo comparator | –Treatment consists on traditional memory training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Multiple sclerosis
Key exclusion criteria (1 listed)
- Diagnosis of other neurological conditions
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 |
|---|---|---|
| Self-generation treatmentself-generation treatment is a cognitive rehabilitation strategy aimed to improve memory. The self-generation strategy treatment, embedded within practice of various activities will consists of six individualized intervention sessions administered over 2-3 weeks | Behavioural | Self-generation treatment |
Primary outcome
Neuropsychological Assessment
Time frame: Baseline assessment, and Week 3
1 secondary outcome
Assessment of Global Functioning
Time frame: Baseline and Week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Derived from this study: PubMed 28485659Goverover Y, Chiaravalloti N, Genova H, DeLuca J. A randomized controlled trial to treat impaired learning and memory in multiple sclerosis: The self-GEN trial. Mult Scler. 2018 Jul;24(8):1096-1104. doi: 10.1177/1352458517709955. Epub 2017 May 9.
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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.
Yael Goverover, PhD principal investigator
Kessler Foundation
John DeLuca, 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 Self-generation treatment 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Goverover, PhD (212-998-5854, yg243@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Assessment (time frame: Baseline assessment, and Week 3). 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 NCT02032589, 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 10 Jan 2014.