EpilepsyNCT02726191
Computerized Cognitive Training in Epilepsy
A study testing Spatial Match Exercise, Temporal Sequence Reconstruction Exercise and Token Task Exercise in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Spatial Match Exercise, Temporal Sequence Reconstruction Exercise and Token Task Exercise
- 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
- Jan 2017to Apr 2018
- 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
- Healthy volunteers accepted
- 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.
- Must own a computer or have access to the internet.
Who cannot join
- Full Scale IQ < 80, as assessed by the WASI-II.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). 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.
- 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.
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
The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.
Read the detailed description
The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.
- Conditions
- Epilepsy
- Being tested
- Spatial Match Exercise, Temporal Sequence Reconstruction Exercise, Token Task Exercise, Story Recall Exercise, Sample-Match (Within Modality) Exercise
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial Match ExerciseBehavioural
Temporal Sequence Reconstruction ExerciseBehavioural
Token Task ExerciseBehavioural
Story Recall ExerciseBehavioural
Sample-Match (Within Modality) ExerciseBehavioural
Pair-Match (Across-Modality) ExerciseBehavioural
Triad-FiguresExerciseBehavioural
Monster Garden ExerciseBehavioural
Memory Match ExerciseBehavioural
Memory Matrix ExerciseBehavioural
Familiar Faces ExercisesBehavioural
Lost in Migration ExerciseBehavioural
Playing Koi ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Posit Science | Experimental | Not described Receives: Behavioral: Spatial Match Exercise; Behavioral: Temporal Sequence Reconstruction Exercise; Behavioral: Token Task Exercise; Behavioral: Story Recall Exercise; Behavioral: Sample-Match (Within Modality) Exercise; Behavioral: Pair-Match (Across-Modality) Exercise; Behavioral: Triad-FiguresExercise |
| Lumosity | Experimental | Not described Receives: Behavioral: Monster Garden Exercise; Behavioral: Memory Match Exercise; Behavioral: Memory Matrix Exercise; Behavioral: Familiar Faces Exercises; Behavioral: Lost in Migration Exercise; Behavioral: Playing Koi Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
Measured: 8 Weeks
Secondary outcomes (3)
The Everyday Cognition Scale (ECog)
Measured: 8 Weeks
Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
Measured: 8 Weeks
Measure of mood (Geriatric Depression Scale)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2017
- Study completionApr 2018 (estimated)
Why it stopped: Study Lapsed
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Karantzoulis, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726191
- Sponsor's protocol ID
- 15-00398
- Status last verified
- Jul 2017
- First submitted
- 22 Mar 2016
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training in Epilepsy
- ClinicalTrials.gov ID
- NCT02726191
- Acronym / sponsor ID
- 15-00398
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Lapsed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2017 (actual)
- Study completion
- Apr 2018 (estimated)
- First posted
- 1 Apr 2016 (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 randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.
Detailed description
The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posit Science | Experimental | Behavioral: Spatial Match Exercise, Behavioral: Temporal Sequence Reconstruction Exercise, Behavioral: Token Task Exercise, Behavioral: Story Recall Exercise, Behavioral: Sample-Match (Within Modality) Exercise, Behavioral: Pair-Match (Across-Modality) Exercise, Behavioral: Triad-FiguresExercise |
| Lumosity | Experimental | Behavioral: Monster Garden Exercise, Behavioral: Memory Match Exercise, Behavioral: Memory Matrix Exercise, Behavioral: Familiar Faces Exercises, Behavioral: Lost in Migration Exercise, Behavioral: Playing Koi Exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 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.
- Must own a computer or have access to the internet.
Key exclusion criteria (5 listed)
- Full Scale IQ < 80, as assessed by the WASI-II.
- History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.
- History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). 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.
- 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.
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 |
|---|---|---|
| Spatial Match Exercise | Behavioural | Posit Science |
| Temporal Sequence Reconstruction Exercise | Behavioural | Posit Science |
| Token Task Exercise | Behavioural | Posit Science |
| Story Recall Exercise | Behavioural | Posit Science |
| Sample-Match (Within Modality) Exercise | Behavioural | Posit Science |
| Pair-Match (Across-Modality) Exercise | Behavioural | Posit Science |
| Triad-FiguresExercise | Behavioural | Posit Science |
| Monster Garden Exercise | Behavioural | Lumosity |
| Memory Match Exercise | Behavioural | Lumosity |
| Memory Matrix Exercise | Behavioural | Lumosity |
| Familiar Faces Exercises | Behavioural | Lumosity |
| Lost in Migration Exercise | Behavioural | Lumosity |
| Playing Koi Exercise | Behavioural | Lumosity |
Primary outcome
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)
Time frame: 8 Weeks
3 secondary outcomes
The Everyday Cognition Scale (ECog)
Time frame: 8 Weeks
Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)
Time frame: 8 Weeks
Measure of mood (Geriatric Depression Scale)
Time frame: 8 Weeks
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 18 Jul 2017.
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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.
Stella Karantzoulis, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial Match Exercise, Temporal Sequence Reconstruction Exercise and Token Task Exercise 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 2 inclusion and 5 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 18 Jul 2017. 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?
Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS) (time frame: 8 Weeks). 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 18 Jul 2017.