EpilepsyNCT03644082
Computerized Cognitive Training for Patients With Epilepsy
A study testing Luminosity Trial Memory Match, Luminosity Trial Memory Matrix and Luminosity Trial Famliar Faces in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Luminosity Trial Memory Match, Luminosity Trial Memory Matrix and Luminosity Trial Famliar Faces
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2020to 30 Apr 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
- Presence of memory disturbance, as defined by an immediate or delayed memory index score < 85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Availability of a home computer and internet for access to the computer training program.
Who cannot join
- Full Scale IQ < 80, as assessed by an appropriate Wechsler scale (WAIS-IV or WASI-II).
- Epilepsy surgery within 8 weeks of the beginning of the trial.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Alzheimer's disease, multiple sclerosis, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia or bipolar disorder). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
- Visual or auditory impairment, which precludes participation in part, or all of the testing or computer training.
- English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for >10 years.
- Previous exposure (> one week) to Lumosity or a similar computerized training program.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Individuals meeting inclusion criteria will be screened for the presence of memory disturbance (defined by results of neuropsychological testing) and lack of exposure to any previous form of computerized cognitive training. All eligible subjects will be provided with an account for Lumosity with instructions to complete training modules 5 days per week for a total of 8 consecutive weeks. Outcomes will be evaluated through changes on the neuropsychological test battery.
- Conditions
- Epilepsy
- Being tested
- Luminosity Trial Memory Match, Luminosity Trial Memory Matrix, Luminosity Trial Famliar Faces, Luminosity Trial Brain Shift, Luminosity Trial Star Search
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminosity Trial Memory MatchBehavioural
Working memory task that has users indicate whether the current symbol matches the one presented 2 symbols previously. As the user makes correct responses, the previous symbols reduce in contrast and fade int the background, ultimately disappearing, forcing the user to rely entirely on working memory to achieve success
Luminosity Trial Memory MatrixBehavioural
The purpose id to remember the location of squares on a grid
Luminosity Trial Famliar FacesBehavioural
The purpose is to create associations between visual and verbal information
Luminosity Trial Brain ShiftBehavioural
The purpose is to decide whether or not cards with numbers and letters are either even or vowels. This measures inhibition, flexibility, and monitoring response set. Also, letterfluency, category fluency, and category switching.
Luminosity Trial Star SearchBehavioural
The purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention.
Luminosity Trial Word BubblesBehavioural
The purpose is to decide what suffix to use in order to complete a word whena prefix is given. The subject needs to come up with he ending of three different prefixes to complete the word.
This task measures verbal modality, deductive reasoning, integration of multiple bits of information, and flexibility of thinking.
Luminosity Trial Color MatchBehavioural
The purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response
Luminosity Trial Ebb and FlowBehavioural
Identify which direction leaves are pointing or moving depending on their color.This measures inhibition of impulsive and perseverative responding, and the ability to establish and maintain instructional set.
Luminosity TrialChalk Board ChallengeBehavioural
purpose is to problem solve quantitative reasoningequationsand to decide which card is greater or if the 2 cards are equal when the math problem is solved.
Luminosiuty Follow that FrogBehavioural
The purposeis to remember the path a red frog takes as it jump from lilypad to lily pad in a pond. This measures flexibility of thinking on a visual-motor sequencing task and working memory
Luminosity Train of ThoughtBehavioural
purpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Patients | Experimental | Not described Receives: Behavioral: Luminosity Trial Memory Match; Behavioral: Luminosity Trial Memory Matrix; Behavioral: Luminosity Trial Famliar Faces; Behavioral: Luminosity Trial Brain Shift; Behavioral: Luminosity Trial Star Search; Behavioral: Luminosity Trial Word Bubbles; Behavioral: Luminosity Trial Color Match; Behavioral: Luminosity Trial Ebb and Flow; Behavioral: Luminosity TrialChalk Board Challenge; Behavioral: Luminosiuty Follow that Frog; Behavioral: Luminosity Train of Thought |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Memory Index Score
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Measured: 12 Months
Delayed Memory Index Score
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startDec 2020 (estimated)
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Problems recruiting and retaining volunteer research personnel to assist with the recruitment of subjects and the study procedures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Barr, MD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644082
- Sponsor's protocol ID
- 17-01830
- Status last verified
- Jun 2021
- First submitted
- 21 Aug 2018
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training for Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT03644082
- Acronym / sponsor ID
- 17-01830
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems recruiting and retaining volunteer research personnel to assist with the recruitment of subjects and the study procedures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Aug 2018 (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.
This is a study on the effectiveness of computerized cognitive training for treatment of memory disorders in patients with epilepsy. Participants will be recruited from patients referred for neuropsychological assessment through the NYU Comprehensive Epilepsy Center's inpatient and outpatient services. Individuals meeting inclusion criteria will be screened for the presence of memory disturbance (defined by results of neuropsychological testing) and lack of exposure to any previous form of computerized cognitive training. All eligible subjects will be provided with an account for Lumosity with instructions to complete training modules 5 days per week for a total of 8 consecutive weeks. Outcomes will be evaluated through changes on the neuropsychological test battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Patients | Experimental | Behavioral: Luminosity Trial Memory Match, Behavioral: Luminosity Trial Memory Matrix, Behavioral: Luminosity Trial Famliar Faces, Behavioral: Luminosity Trial Brain Shift, Behavioral: Luminosity Trial Star Search, Behavioral: Luminosity Trial Word Bubbles, Behavioral: Luminosity Trial Color Match, Behavioral: Luminosity Trial Ebb and Flow, Behavioral: Luminosity TrialChalk Board Challenge, Behavioral: Luminosiuty Follow that Frog, Behavioral: Luminosity Train of Thought |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.
- Presence of memory disturbance, as defined by an immediate or delayed memory index score < 85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Availability of a home computer and internet for access to the computer training program.
Key exclusion criteria (7 listed)
- Full Scale IQ < 80, as assessed by an appropriate Wechsler scale (WAIS-IV or WASI-II).
- Epilepsy surgery within 8 weeks of the beginning of the trial.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Alzheimer's disease, multiple sclerosis, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia or bipolar disorder). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.
- Visual or auditory impairment, which precludes participation in part, or all of the testing or computer training.
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 |
|---|---|---|
| Luminosity Trial Memory MatchWorking memory task that has users indicate whether the current symbol matches the one presented 2 symbols previously. As the user makes correct responses, the previous symbols reduce in contrast and fade int the background, ultimately disappearing, forcing the user to rely entirely on working memory to achieve success | Behavioural | Epilepsy Patients |
| Luminosity Trial Memory MatrixThe purpose id to remember the location of squares on a grid | Behavioural | Epilepsy Patients |
| Luminosity Trial Famliar FacesThe purpose is to create associations between visual and verbal information | Behavioural | Epilepsy Patients |
| Luminosity Trial Brain ShiftThe purpose is to decide whether or not cards with numbers and letters are either even or vowels. This measures inhibition, flexibility, and monitoring response set. Also, letterfluency, category fluency, and category switching. | Behavioural | Epilepsy Patients |
| Luminosity Trial Star SearchThe purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention. | Behavioural | Epilepsy Patients |
| Luminosity Trial Word BubblesThe purpose is to decide what suffix to use in order to complete a word whena prefix is given. The subject needs to come up with he ending of three different prefixes to complete the word. This task measures verbal modality, deductive reasoning, integration of multiple bits of information, and flexibility of thinking. | Behavioural | Epilepsy Patients |
| Luminosity Trial Color MatchThe purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response | Behavioural | Epilepsy Patients |
| Luminosity Trial Ebb and FlowIdentify which direction leaves are pointing or moving depending on their color.This measures inhibition of impulsive and perseverative responding, and the ability to establish and maintain instructional set. | Behavioural | Epilepsy Patients |
| Luminosity TrialChalk Board Challengepurpose is to problem solve quantitative reasoningequationsand to decide which card is greater or if the 2 cards are equal when the math problem is solved. | Behavioural | Epilepsy Patients |
| Luminosiuty Follow that FrogThe purposeis to remember the path a red frog takes as it jump from lilypad to lily pad in a pond. This measures flexibility of thinking on a visual-motor sequencing task and working memory | Behavioural | Epilepsy Patients |
| Luminosity Train of Thoughtpurpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention. | Behavioural | Epilepsy Patients |
Primary outcome
Immediate Memory Index Score
Time frame: 12 Months
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Delayed Memory Index Score
Time frame: 12 Months
Score on the Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS) will be used to measure immediate memory
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
William Barr, MD study director
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminosity Trial Memory Match, Luminosity Trial Memory Matrix and Luminosity Trial Famliar Faces in people with Epilepsy, run by NYU Langone Health 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 7 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: withdrawn, as of the sponsor's last update on 1 Jul 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Immediate Memory Index Score (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 Jul 2021.