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The clinical trial to evaluate the efficacy of [11C]K-2 in epilepsy patients

Completed
Conditions
refractory epilepsy patients
Registration Number
jRCTs031180191
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
8
Inclusion Criteria

1.refractory epilepsy patients(mesial temporal lobe epilepsy)
2.patinets for anterior temporal lobectomy(ATL)
3.patients who are without cerebral surgery on the same side of ATL
4.patients who are 20 years or older
5.patients who can consent to this study by oneself

Exclusion Criteria

1.patients who have significant abnormalities insides the brains
2.patients who have experienced the electric stimulation therapy
3.patients who undergo artificial dialysis
4.patients who have severe liver dysfunction
5.patients who have tatoo
6.claustrophobic patients
7.breast-feeding mothers, expecting mothers, females who desire to be a mother
8.patients who desire to bear a child within this study period
9.patients who take Fycompa
10.patients who underwent nuclear medicine examination within one-week before this registarion
11.patients who underwent other clinical trials using unapproved nuclear medicine examination within six month before this registarion
12.patients who underwent other clinical trials within 12 weeks before this registarion
13.patients whom study doctors consider unappropriate

Study & Design

Study Type
Interventional
Study Design
single assignment
Primary Outcome Measures
NameTimeMethod
-

The correlation of the AMPA receptors densities examined by biochemical study and [11C]K-2 PET study

Secondary Outcome Measures
NameTimeMethod
Density of AMPA receptors and FDG-PET values

Obtained from preoperative [11C]K-2 PET imaging

Cognitive function scores (IQ, MQ)

Quantitative changes in cognitive function scores around surgery

Prescribed anti-epileptic drugs

Quantitative changes in the number of types and the dose per day after surgery

Adverse events7 days after PET scan

The adverse events occurred in patients

Engel classification and ILAE classification

Evaluation of postoperative epileptic seizures

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