The gole in this study is treatment effect evaluation of electroconvulsive therapy in seven Lennox-gastaut syndrom and medicaly refractory epileptic patients. These patients have at least one disabeling seizure as tonic-clonic or drop attack per weak and they have no serious concomitant medical illness or pseudoseizure. At the month befor intervention we will evaluate baseline disabeling seizure frequency. they will undergo electroconvulsive therapy 3 times aweak for the first month and then weakly for 3 months.Finally last month disabeling seizures will be compared with the month before intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062111778N2
Registration date:2014-10-25, 1393/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-25, 1393/08/03
Registrant information
Name
Seyed mohammad ali Razavizadegan Jahromi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71123054109
Email address
razavima@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancelor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2014-05-25, 1393/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adjunctive treatment use of electroconvulsive therapy in seven patients with Lennox-Gastaut syndrome and medically-refractory epilepsy
Public title
Effect of ECT on treatment of medically refractory epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were:
male / female patients, age five years and older؛ diagnosis of LGS made on the basis of electro-clinical findings؛ medically-refractory seizures defined as failure of two or more AEDs at maximal tolerated doses and one or more disabling seizures (e.g., generalized tonic-clonic seizures and / or drop attacks) per week؛ They had stable medication regimen for four weeks prior to entry؛ Informed consent by patients was obtained؛
Exclusion criteria were:
Patients younger than 5 y/o; patients with progressive neurological conditions; having any serious medical (particularly cardiac) illness or major psychiatric disorder or history of psychogenic non-epileptic seizures.
Age
From 5 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
7
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences- Karimkhan Zand street- Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
CT-P-9360-6910
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40.4
ICD-10 code description
Lennox-Gastaut syndrome
Primary outcomes
1
Description
decreasing seizure frequensy
Timepoint
comparing seizure frequensy 10-16 and 22 weaks after intervention to 4 weaks befor
Method of measurement
seizure frequensy calendar
Secondary outcomes
1
Description
intervention compliance
Timepoint
weakly
Method of measurement
frequent visit
Intervention groups
1
Description
1-each patient compare with himself
2-bitemporal ECT as below:3 times aweak for the first month and weakly for the 3 months after
3-adjusting minimal energy for ECT device that induces clinical seizure
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Seyyed Mohammad Ali Rzavizadegan Jahromi
Street address
Irannaja Hospital, Paramont crossway, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice president of research at Shiraz University of Medical Sciences
Street address
7 floor, central beelding, Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
NAJA
Full name of responsible person
Seyyed Mohammad Ali Razavizadegan Jahromi
Position
Neurologist
Other areas of specialty/work
Street address
Irannaja Hospital, Paramont cross way, shiraz
City
Shiraz
Postal code
Phone
+98 71 1218 8818
Fax
Email
mrazavizadegan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Naja
Full name of responsible person
Seyyed Mohammad Ali Razavizadegan Jahromi
Position
neurologist
Other areas of specialty/work
Street address
Irannaja hospital, Paramont cross way, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1218 8818
Fax
Email
mrazavizadegan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
NAJA
Full name of responsible person
Seyyed Mohammad Ali Razavizadegan Jahromi
Position
neurologist
Other areas of specialty/work
Street address
Irannaja hospital, Paramont cross way, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1218 8818
Fax
Email
mrazavizadegan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)