Temporal lobe epilepsy (TLE) is the most common form of human partial epilepsy and is poorly controlled by the pro-GABAergic or anti Na-channel drugs that form the basis of current pharmacotherapy. Instead, the preferred therapy for patients with pharmacoresistant epilepsies associated with hippocampal sclerosis is to define the site of the epileptogenic focus, and to remove this region surgically. We want to test Bumetanide effect as a substitute treatment for surgery in controlling temporal lobe epilepsy. Our study population will be 5 patients suffering from drug resistant temporal lobe epilepsy who are candidate for surgery. People who have contraindication for Bumetanide will be excluded from this study. Patients will receive this medicine orally for 3 months. Then we will test the effect of Bumetanide in decreasing seizures as well as its effects on interictal events.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012115368N1
Registration date:2011-02-05, 1389/11/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-02-05, 1389/11/16
Registrant information
Name
Mahmoudreza Hadjighassem
Name of organization / entity
Brain and Spinal Cord Injury research center, SAchool of advanced medical technologies, Tehran Unive
Country
Iran (Islamic Republic of)
Phone
+98 21665815601
Email address
drhadjighassem@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cellular and Molecular Research Center, Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Bumethanide treatment on seizure controlling in patients with drug resistance temporal lobe epilepsies candidate for surgery
Public title
The effect of Bumethanide treatment on seizure controlling in patients with drug resistance temporal lobe epilepsies candidate for surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 1) Suffering from drug resistance temporal lobe epilepsy 2) Candidate for temporal lobectomy 3) Giving informed consent.
Exclusion: Contraindication for Bumethanide
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Cellular and Molecular Research Center of Tehran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2011-01-02, 1389/10/12
Ethics committee reference number
م ت/4333
Health conditions studied
1
Description of health condition studied
Temporal Lobe Epilepsy
ICD-10 code
G40.8
ICD-10 code description
other epilepsy
Primary outcomes
1
Description
seizure occurrence
Timepoint
1 month before and 1 month after intervention
Method of measurement
EEG
Secondary outcomes
1
Description
dose reduction of anti-epileptic drugs
Timepoint
3 months before and 3 months after intervention
Method of measurement
dosage
Intervention groups
1
Description
Bumetanide (1mg/day) orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Seizure Center, Khatamolanbia Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cellular and Molecular Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr.Hadjighassem
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cellular and Molecular Research Center of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Cellular and Molecular Research Center
Full name of responsible person
Mahmoudreza Hadjighassem
Position
MD-PhD
Other areas of specialty/work
Street address
Cellular and Molecular Research Center, Tehran University of Medical Sciences and Health Services, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8805 2984
Fax
Email
drhadjighassem@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cellular and Molecular Research Center
Full name of responsible person
Mahmoudreza Hadjighassem
Position
MD-PhD in Neuroscience
Other areas of specialty/work
Street address
Cellular and Molecular Research Center, Tehran University of Medical Sciences and Health Services, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8805 2984
Fax
Email
drhadjighassem@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cellular and Molecular Research Center
Full name of responsible person
Sanaz Eftekhari
Position
MD- PhD student in Neuroscience
Other areas of specialty/work
Street address
Cellular and Molecular Research Center, Tehran University of Medical Sciences and Health Services, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8805 2984
Fax
Email
stahoora@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)