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Evaluating the effectiveness of transcranial direct current stimulation (tDCS) in the management of patiants with super-refractory status epilepticus: A randomized clinial trial study

Protocol summary

Study aim
Determining the effectiveness of transcranial direct current stimulation (tDCS) in the management of patients with super-refractory status epilepticus
Design
A phase 3 RCT with 20 patients with super-refractory status epilepticus in each case and control group in parallel without blinding
Settings and conduct
This study is conducted in the CPR of Shiraz Namazi Hospital on patients with epilepsy resistant to drug treatment. After consulting the neurology service, the patients will be visited by the resident, history and physical examination, and routine laboratory tests including CBC, BUN, Cr, Ca, Mg, ph are taken, and if they meet the inclusion criteria they will be randomly placed in one of the groups. Also, EEG will be taken before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-aged 18 to 70 years old 2-Diagnosis of super-refractory status epilepticus Exclusion criteria: 1-Psychological seizures and Suffering from major psychological diseases 2-sepsis and multi-organ failure 3-pregnancy
Intervention groups
The intervention group includes patients with drug-resistant super-refractory status epilepticus resistance to drug treatment admitted to this center. Also, they should not have the following conditions: drug addiction, metabolic diseases that cause seizures, pregnancy, skull defects, and the presence of other electrical devices to treat various diseases. This group receives the intervention in the form of two electrical stimulations for 20 minutes on each side. The comparison group includes patients with drug-resistant super-refractory status epilepticus who compared to the intervention in the form of installing LEDs in the right place without receiving stimulation, only with EEG.
Main outcome variables
changes of convulsive movements; number of epileptiform waves in EEG

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230209057371N1
Registration date: 2023-10-21, 1402/07/29
Registration timing: registered_while_recruiting

Last update: 2023-10-21, 1402/07/29
Update count: 0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Maryam Rohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4968
Email address
rohani_maryam96@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-10-01, 1403/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of transcranial direct current stimulation (tDCS) in the management of patiants with super-refractory status epilepticus: A randomized clinial trial study
Public title
Evaluation of the effect of intracranial direct current in patients with seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18 to 70 years patients diagnosed with super refractory status epilepticus type of tonic-clonic seizure admitted to the cardiopulmonary resuscitation (CPR) ward or the emergency room of Namazi Hospital, Shiraz, Iran.
Exclusion criteria:
Psychological seizures or Suffering from major psychological diseases Drug addiction Metabolic diseases causing seizures Pregnancy Skull abnormalities The existence of other electrical devices for the treatment of various diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using the block method of 20 pieces of paper written: TCDS and on the other 20 pieces "No intervention" will be written. Then all the crumpled papers will be poured into a container and mixed. Then, they will be taken out one by one and entered into the list from number 1 to 40. After that, forty sealed envelopes, which will be numbered up to 40 on the back, and the corresponding intervention method written inside each one, will be kept in the department's closet, and when each patient enters the study, the corresponding envelope will open in order and According to the written text, appropriate action will be taken.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand str., Shiraz medical school
City
Shiraz
Province
Fars
Postal code
7134846114
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.SUMS.MED.REC.1402.043

Health conditions studied

1

Description of health condition studied
super-refractory status epilepticus
ICD-10 code
G40.803
ICD-10 code description
Other epilepsy, intractable, with status epilepticus

Primary outcomes

1

Description
Evaluate the change in the convulsive movements
Timepoint
From the beginning of the seizure and its end till 24 hours
Method of measurement
By physical examination and direct observation of the presence or absence of any tonic, clonic, and myoclonic convulsive movements of the patient by the neurology assistant.

2

Description
Epileptiform waves in the electroencephalography (EEG)
Timepoint
30 minutes before and after the intervention
Method of measurement
Electroencephalograph

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients whose seizures did not stop 24 hours after general anesthesia despite receiving standard seizure treatment drugs (intervention number 2) receive twice intracranial direct current stimulation by operating the relevant leads for 20 minutes at the rate of 2 milliamps, electrical stimulation will be done once in F4 and T5 areas and once again in the opposite side header in F3 and T6 areas.
Category
Treatment - Other

2

Description
All patients in each group will receive standard seizure treatments as usual (usually benzodiazepine drugs are used in the first stage of treatment.) If the seizures do not stop, intravenous anticonvulsants such as fennel are used in the next stage. Tween, levotirastam or valproate are used. If after two hours there is still evidence of continued seizures despite the steps 1 and 2, the patient will be put under general anesthesia and there will be no interruption in their usual treatment process.
Category
Treatment - Drugs

3

Description
Intervention group: History, physical examination, and blood sample for ca, Mg, phosphorus, BUN, Cr for the diagnosis and evaluation
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Maryam Rohani
Street address
Namazi hospital, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3231 9049
Fax
+98 71 3231 9049
Email
rohani_maryam96@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeian Zadeh
Street address
Shiraz, Zand St., central building of Shiraz University of Medical Sciences, 7th floor, research unit
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
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
Maryam Rohani
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Namazi Hospital- Namazi square
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3647 4968
Fax
Email
rohani_maryam96@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Rohani
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Namazi Hospital- Namazi square
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3647 4968
Fax
Email
rohani_maryam96@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Namazi hospital, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3647 4968
Email
rohani_maryam96@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"there is no further information"
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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