EpilepsyNCT00486239
Emotional Processing and Memory Evaluation in Epilepsy Patients
A study testing TLE Arm 1, Emotion Memory Test and Emotion Memory Testing in people with Epilepsy, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory and emotional functioning. The study will evaluate the known lateralized neurological dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- TLE Arm 1, Emotion Memory Test and Emotion Memory Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2010
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Referred to neurological institute at University Hospitals Case Medical Center for care of seizures/epilepsy
- Referred to neuropsychology laboratory for evaluation
- Participants must complete the routine check-in of all patients and sign consent and HIPAA forms.
- Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable.
- Be aged 18-64 years old.
- Be able to provide documented informed consent.
- Have a confirmed diagnosis of right or left temporal lobe epilepsy (TLE), which is made independent of their pre-surgical neuropsychological evaluation. Neurological disease must be confirmed by one (or more) of the following: (a) MRI study of the head, (b) CT study of the head, (c) EEG study, (d) Video-EEG study, (e) PET study of the head, (f) Neurological and Psychiatric exam by a physician.
Who cannot join
- Referred from an attorney or their evaluation is part of a personal injury claim.
- Be intoxicated from alcohol or other illicit substance.
- Received Electroconvulsive (ECT) treatment within the last 21 days.
- Have an MMSE score of 25 or less
- Have undergone Deep Brain Stimulator (DBS) surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory and emotional functioning. The study will evaluate the known lateralized neurological dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study data will assess the ability of participants with known lateralized neurological dysfunction (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component of the study will evaluate possible changes in memory function for emotionally charged material following right or left temporal lobectomy for the treatment of medically intractable epilepsy. It is expected participants with known lateralized dysfunction will exhibit differential ability to discriminate emotional charged visual and verbal material.
Read the detailed description
Epilepsy is a relatively common neurological disorder diagnosed when individuals suffer from repeated unprovoked seizures. Estimates of prevalence rates vary, but it is generally considered to be about 1% of the U.S. population. Of the patients diagnosed with epilepsy, about 60-70 percent are diagnosed with complex-partial seizures, and of these about 30-40 percent are medication refractory. The majority of individuals with medically refractory epilepsy have seizures arising from the temporal lobe area, labeled as Temporal Lobe Epilepsy (TLE). Patients with TLE experience neurological and psychiatric comorbidity. The surgical treatment of patients with medically refractory epilepsy has become increasingly recognized as an effective treatment to reduce or eliminate seizures in selected patients. Up to 90 percent of selected participants with TLE have been seizure free for a year following temporal lobectomy. However, patients undergoing neurological surgery for medication refractory epilepsy can experience a variety of cognitive and emotional comorbid complications. These include declines in memory and language functions as well as onset of depression, anxiety, and, rarely, de novo psychosis has been reported. This study will assess the material specific memory and emotion functioning of subjects with medically refractory temporal lobe epilepsy.
The incorporation of neuropsychological assessment in the pre-surgical evaluation of patients diagnosed with medically refractory epilepsy has been successful in reducing the risk of individuals experiencing catastrophic declines in memory and language functioning following neurological surgery. However, material specific memory loss remains a problematic issue in the surgical treatment for TLE. Despite 30 years of research, there remains questions about the lateralized function of mesial temporal structures. In addition, it has become increasingly recognized emotional function in patients with medically refractory epilepsy are related to quality of life and functional outcomes following temporal lobectomy. Indeed, post-surgical symptoms of depression and anxiety are significantly related to patient quality of life and, to a lesser extent, seizure freedom. Initial results suggested patients with right TLE were at greater risk for post-surgical emotional difficulties; however, more recent data question earlier observations and suggest hemisphere dominance has little affect on psychiatric outcome.
There is little doubt neurological surgery for medically refractory can significantly decrease, and in many instances, eliminate seizures in patients. However, individuals are at risk for cognitive and emotional comorbidity with these medical treatments and there remains a paucity of empirical study to help guide treatment. Despite increasing empirical evaluation of emotional (psychiatric) status in individuals with medically refractory epilepsy, there is a paucity of data exploring the interaction of learning and emotion functions. The purpose of this study is to prospectively evaluate the memory functioning of individuals with medically refractory TLE for emotional material. In addition, a component of the study will evaluate if there are differences in the ability to evaluate the emotional content of stimuli. Data from participants with epilepsy will be compared to a control group of healthy volunteers. The stimuli will consist of positive and negative material. It is suspected these data will, in the future, improve the pre-surgical evaluation of individuals with medically refractory epilepsy and reduce risk of the person having a pronounced psychiatric complication following temporal lobectomy.
- Conditions
- Epilepsy
- Being tested
- TLE Arm 1, Emotion Memory Test, Emotion Memory Testing
- Keywords
- Epilepsy, memory, emotion
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLE Arm 1Behavioural
Behavioral/cognitive testing
Emotion Memory TestBehavioural
Behavioral/cognitive Measure
Emotion Memory TestingBehavioural
Behavioral/cognitive testing
Emotion Memory TestingBehavioural
Behavioral/cognitive testing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral TLE 1A Receives: Behavioral: TLE Arm 1; Behavioral: Emotion Memory Test |
| 2 | Experimental | TLE Arm II Receives: Behavioral: Emotion Memory Testing |
| B | Experimental | Control Arm B Receives: Behavioral: Emotion Memory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effects of known lateralized neurological dysfunction (Right TLE versus Left TLE) on emotional memory function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2010
- Study completionMar 2010
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mike R Schoenberg, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486239
- Sponsor's protocol ID
- 08-06-06
- Status last verified
- May 2022
- First submitted
- 13 Jun 2007
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Processing and Memory Evaluation in Epilepsy Patients
- ClinicalTrials.gov ID
- NCT00486239
- Acronym / sponsor ID
- 08-06-06
- Conditions
- Epilepsy
- Keywords
- Epilepsy, memory, emotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Oct 2006 (actual)
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Jun 2007 (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 the study is to assess the effects of temporal lobe epilepsy (TLE) on memory and emotional functioning. The study will evaluate the known lateralized neurological dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study data will assess the ability of participants with known lateralized neurological dysfunction (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component of the study will evaluate possible changes in memory function for emotionally charged material following right or left temporal lobectomy for the treatment of medically intractable epilepsy. It is expected participants with known lateralized dysfunction will exhibit differential ability to discriminate emotional charged visual and verbal material.
Detailed description
Epilepsy is a relatively common neurological disorder diagnosed when individuals suffer from repeated unprovoked seizures. Estimates of prevalence rates vary, but it is generally considered to be about 1% of the U.S. population. Of the patients diagnosed with epilepsy, about 60-70 percent are diagnosed with complex-partial seizures, and of these about 30-40 percent are medication refractory. The majority of individuals with medically refractory epilepsy have seizures arising from the temporal lobe area, labeled as Temporal Lobe Epilepsy (TLE). Patients with TLE experience neurological and psychiatric comorbidity. The surgical treatment of patients with medically refractory epilepsy has become increasingly recognized as an effective treatment to reduce or eliminate seizures in selected patients. Up to 90 percent of selected participants with TLE have been seizure free for a year following temporal lobectomy. However, patients undergoing neurological surgery for medication refractory epilepsy can experience a variety of cognitive and emotional comorbid complications. These include declines in memory and language functions as well as onset of depression, anxiety, and, rarely, de novo psychosis has been reported. This study will assess the material specific memory and emotion functioning of subjects with medically refractory temporal lobe epilepsy.
The incorporation of neuropsychological assessment in the pre-surgical evaluation of patients diagnosed with medically refractory epilepsy has been successful in reducing the risk of individuals experiencing catastrophic declines in memory and language functioning following neurological surgery. However, material specific memory loss remains a problematic issue in the surgical treatment for TLE. Despite 30 years of research, there remains questions about the lateralized function of mesial temporal structures. In addition, it has become increasingly recognized emotional function in patients with medically refractory epilepsy are related to quality of life and functional outcomes following temporal lobectomy. Indeed, post-surgical symptoms of depression and anxiety are significantly related to patient quality of life and, to a lesser extent, seizure freedom. Initial results suggested patients with right TLE were at greater risk for post-surgical emotional difficulties; however, more recent data question earlier observations and suggest hemisphere dominance has little affect on psychiatric outcome.
There is little doubt neurological surgery for medically refractory can significantly decrease, and in many instances, eliminate seizures in patients. However, individuals are at risk for cognitive and emotional comorbidity with these medical treatments and there remains a paucity of empirical study to help guide treatment. Despite increasing empirical evaluation of emotional (psychiatric) status in individuals with medically refractory epilepsy, there is a paucity of data exploring the interaction of learning and emotion functions. The purpose of this study is to prospectively evaluate the memory functioning of individuals with medically refractory TLE for emotional material. In addition, a component of the study will evaluate if there are differences in the ability to evaluate the emotional content of stimuli. Data from participants with epilepsy will be compared to a control group of healthy volunteers. The stimuli will consist of positive and negative material. It is suspected these data will, in the future, improve the pre-surgical evaluation of individuals with medically refractory epilepsy and reduce risk of the person having a pronounced psychiatric complication following temporal lobectomy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: TLE Arm 1, Behavioral: Emotion Memory TestBehavioral TLE 1A |
| 2 | Experimental | Behavioral: Emotion Memory TestingTLE Arm II |
| B | Experimental | Behavioral: Emotion Memory TestingControl Arm B |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Referred to neurological institute at University Hospitals Case Medical Center for care of seizures/epilepsy
- Referred to neuropsychology laboratory for evaluation
- Participants must complete the routine check-in of all patients and sign consent and HIPAA forms.
- Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable.
- Be aged 18-64 years old.
Key exclusion criteria (5 listed)
- Referred from an attorney or their evaluation is part of a personal injury claim.
- Be intoxicated from alcohol or other illicit substance.
- Received Electroconvulsive (ECT) treatment within the last 21 days.
- Have an MMSE score of 25 or less
- Have undergone Deep Brain Stimulator (DBS) surgery
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 |
|---|---|---|
| TLE Arm 1Behavioral/cognitive testing | Behavioural | 1 |
| Emotion Memory TestBehavioral/cognitive Measure | Behavioural | 1 |
| Emotion Memory TestingBehavioral/cognitive testing | Behavioural | 2 |
| Emotion Memory TestingBehavioral/cognitive testing | Behavioural | B |
Primary outcome
Evaluate the effects of known lateralized neurological dysfunction (Right TLE versus Left TLE) on emotional memory function.
Time frame: 1 year
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 18 May 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.
Mike R Schoenberg, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLE Arm 1, Emotion Memory Test and Emotion Memory Testing in people with Epilepsy, run by University Hospitals Cleveland Medical Center 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 7 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: finished, as of the sponsor's last update on 18 May 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?
Evaluate the effects of known lateralized neurological dysfunction (Right TLE versus Left TLE) on emotional memory function. (time frame: 1 year). 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 May 2022.