Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00486239 |
| Other study ID # |
08-06-06 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2006 |
| Est. completion date |
March 2010 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospitals Cleveland Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
