The evaluation of the effectiveness of adjunctive application of transcranial direct current stimulation (tDCS) in the management of patients with super-refractory convulsive status epilepticus
The effectiveness of adjunctive application of transcranial direct current stimulation (tDCS) in the management of patients with super-refractory convulsive status epilepticus
Design
An open lable clinical trial as a pilot study with control group and non-randomized parallel intervention group on 20 patient
Settings and conduct
Patients with super-refractory convulsive status epilepticus admitted to hospitals affiliated with Shiraz University of Medical Sciences in the intervention group, as mentioned, will be intervened, whereas patients in the control group will get just standard therapies. The ECG is performed on all patients in the intervention group 30 minutes before and 30 minutes after the intervention. However, in the control group, just one ECG will be performed at the final.
Participants/Inclusion and exclusion criteria
IC: patients with a diagnosis of tonic-clonic super-refractory convulsive status epilepticus
EC: Patients with major psychiatric diseases, drug addiction, Seizures are caused by metabolic abnormalities, pregnancy, skull defects,
Intervention groups
Patients with super-refractory convulsive status epilepticus who receive only conventional therapies as a control group.
Intervention group: Patients with super-refractory status epilepticus who have not responded to standard therapies should be treated with tCSD, which entails implanting the appropriate leads in the T5 and F4 areas and stimulating them once for 20 minutes at a current of 2 mA. For 20 minutes, they will each receive the same amount of electrical stimulation in regions T6 and F3 on the opposite side.
Main outcome variables
Reduction or elimination of convulsive movements in patients; electroencephalogram's background wave; Improving patients' epileptiform discharges ; Improving patients' level of consciousness; Reducing the hospitalization rate of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200517047483N2
Registration date:2022-03-16, 1400/12/25
Registration timing:registered_while_recruiting
Last update:2022-03-16, 1400/12/25
Update count:0
Registration date
2022-03-16, 1400/12/25
Registrant information
Name
Mahtab Rostamhosseinkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3820 6907
Email address
mahtabrostami85@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effectiveness of adjunctive application of transcranial direct current stimulation (tDCS) in the management of patients with super-refractory convulsive status epilepticus
Public title
The evaluation of the effectiveness of transcranial direct current stimulation (tDCS) in the management of super-refractory convulsive status epilepticus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female (non-pregnant female) patients between the ages of 18 and 70 years
Patients with a diagnosis of super-refractory convulsive status epilepticus
Exclusion criteria:
Patients with major psychiatric diseases
Drug addiction
Seizures are caused by metabolic abnormalities.
pregnancy
cranial defects
The existence of additional electrical devices used to treat a variety of disorders
Psychologic nonepileptic seizures
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Sciences Review Board and Ethics Committee (IRCT )
Street address
Namazi Sq., Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.SUMS.MED.REC.1400.561
Health conditions studied
1
Description of health condition studied
Super-refractory convulsive status epilepticus
ICD-10 code
G40.911
ICD-10 code description
Epilepsy, unspecified, intractable, with status epilepticus
Primary outcomes
1
Description
Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in reducing convulsive movements in patients with super-refractory status epilepticus
Timepoint
Evaluation of convulsive movements of patients before the intervention and 30 minutes after the intervention
Method of measurement
According to a neurology resident's direct observation and examination of the patients,
2
Description
Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in improving EEG in patients with super-refractory status epilepticus
Timepoint
Patients' levels of awareness were measured before and 30 minutes after the intervention.
Method of measurement
According to the Glasgow Coma Scale
3
Description
Evaluation of the effectiveness of adjunctive use of intracranial direct current stimulation in improving EEG in patients with super-refractory status epilepticus
Timepoint
Before and 30 minutes after the intervention, get an electroencephalogram.
Method of measurement
electroencephalogram interpretation by a qualified and specialized epileptologist.
Secondary outcomes
empty
Intervention groups
1
Description
control group: Control group: Patients with super-refractory convulsive status epilepticus who will receive all standard treatments for status epilepsy as follows: Normally, benzodiazepines (diazepam or lorazepam, CHEMIDAROU.Co) are used in the first line of treatment. If the seizure does not stop, in the next step, intravenous anticonvulsants such as phenytoin ( Caspian Tamin Co), levetiracetam (COBEL DAROU Co), or intravenous valproate (RAHA Co) are used, and if there is still evidence that the seizure persists after two hours despite treatment steps 1 and 2, the patient will be placed under general anesthesia.
Category
Treatment - Other
2
Description
Intervention group: Patients with super-refractory convulsive status epilepticus who will continue their seizures after receiving the standard treatment for seizures will be electrically stimulated through the skull with tDCS. In this way, after installing the relevant leads in the T5 and F4 areas, they will receive an electrical excitation of 2 mA for 20 minutes and the same amount of electrical excitation on the opposite side in the T6 and F3 areas for 20 minutes. Additionally, they will have an electroencephalogram 30 minutes prior to and 30 minutes following electrical stimulation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Marzie Salimi
Street address
Epilepsy department, Namazi hospital, Namazi Sq, Zand St
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5840
Email
Salimi.md67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpoor
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5840
Email
Salimi.md67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5840
Email
Salimi.md67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Epilepsy Department, Namazi Hospital, Namazi Sq, Zand St.
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3612 5840
Email
Salimi.md67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD is to be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
To help further research to improve the treatment of refractory temporal lobe epilepsy
From where data/document is obtainable
Marzie salimi- Salimi.md67@gmail.com
What processes are involved for a request to access data/document
Send their request to the mentioned email address and within one working week, if there is no problem, the data will be sent to them.