Multiple SclerosisNCT02081508
Consolidation & Interference in Multiple Sclerosis
A study testing Interference onset 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 whether minimizing interference improves memory in multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interference onset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If you are between the ages of 18-65.
- If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
- If you have MS, you have not had a flare up of MS symptoms in the past month.
- You do not have other neurological issues such as, Epilepsy or Stroke.
- You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
- You do not have a significant history of drug or alcohol abuse.
- You can read and speak English fluently.
- You are not currently taking steroids.
Who cannot join
- You are younger than 18 years old.
- You are older than 65 years old.
- You have had a prior stroke or neurological disease other than MS.
- You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
- You have a significant alcohol or drug abuse history.
- You are currently taking steroids.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to investigate whether minimizing interference improves memory in multiple sclerosis.
Read the detailed description
The ability to form new long-lasting memories is important for successful independent living and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis (MS) have difficulty remembering new information and this is likely associated with poor acquisition of new information. There are only a limited number of studies that have investigated memory consolidation in MS. The current study will investigate the role of interference during the consolidation time period of memory formation.
- Conditions
- Multiple Sclerosis
- Being tested
- Interference onset
- Keywords
- Memory
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interference onsetBehavioural
Temporal duration of interference onset.
| Study group | Role | What they receive |
|---|---|---|
| Unfilled interference | Experimental | Interference onset: delayed test at 540000 ms Receives: Behavioral: Interference onset |
| Early interference | Experimental | Interference onset: delayed test at 0 ms Receives: Behavioral: Interference onset |
| Mid interference | Experimental | Interference onset: delayed test at 360000 ms Receives: Behavioral: Interference onset |
| Late interference | Experimental | Interference onset: delayed test at 180000 ms Receives: Behavioral: Interference onset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall Proportion
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Sandry, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081508
- Sponsor's protocol ID
- R-800-13
- Status last verified
- Jul 2016
- First submitted
- 5 Mar 2014
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation & Interference in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02081508
- Acronym / sponsor ID
- R-800-13
- Conditions
- Multiple Sclerosis
- Keywords
- Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Mar 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 whether minimizing interference improves memory in multiple sclerosis.
Detailed description
The ability to form new long-lasting memories is important for successful independent living and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis (MS) have difficulty remembering new information and this is likely associated with poor acquisition of new information. There are only a limited number of studies that have investigated memory consolidation in MS. The current study will investigate the role of interference during the consolidation time period of memory formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Unfilled interference | Experimental | Behavioral: Interference onsetInterference onset: delayed test at 540000 ms |
| Early interference | Experimental | Behavioral: Interference onsetInterference onset: delayed test at 0 ms |
| Mid interference | Experimental | Behavioral: Interference onsetInterference onset: delayed test at 360000 ms |
| Late interference | Experimental | Behavioral: Interference onsetInterference onset: delayed test at 180000 ms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- If you are between the ages of 18-65.
- If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
- If you have MS, you have not had a flare up of MS symptoms in the past month.
- You do not have other neurological issues such as, Epilepsy or Stroke.
- You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
Key exclusion criteria (6 listed)
- You are younger than 18 years old.
- You are older than 65 years old.
- You have had a prior stroke or neurological disease other than MS.
- You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
- You have a 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 |
|---|---|---|
| Interference onsetTemporal duration of interference onset. | Behavioural | Early interference, Late interference, Mid interference, Unfilled interference |
Primary outcome
Recall Proportion
Time frame: 2 hours
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 1 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interference onset 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 8 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: finished, as of the sponsor's last update on 1 Aug 2016. 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?
Recall Proportion (time frame: 2 hours). 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 1 Aug 2016.