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View Clinical Trial (Medical Research Study)
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Emotional Processing and Memory Evaluation in Epilepsy Patients - NCT00486239-44106 (Clinical Trial 172059)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy172059.aspx
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| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44106 |
| Conditions: |
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Epilepsy |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 |
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| Study is available at: |
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University Hospitals Case Medical Center
Cleveland, OH 44106
United States
Primary Contact:
Mike R Schoenberg, PhD
Email: Michael.Schoenberg@UHhospitals.org
Phone: 216-844-3422 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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