The Efficacy of High Definition anodal transcranial direct current stimulation in shortening of duration of hospitalization in Epilepsy Monitoring Unit of patients with drug-resistant epilepsy
Determining the efficacy of brain stimulation in shortening hospitalization in epilepsy monitoring unit patients with refractory epilepsy
Design
Randomised, parallel group (two group) trial with blinded outcome assessment.
Settings and conduct
The present study conducted in the Dr. Bahonar hospital, Kerman and in each group 20 patients were assessed. patients, main investigator and data analyser did not know the patients allocations.
Participants/Inclusion and exclusion criteria
The conditions for entering the study are: 1) patients with drug resistant epilepsy with the criteria of the International League against Epilepsy (ILAE) 2) Age over 18 years 3) Obtaining the signed consent of all patients.
The exclusion criteria are: (1) scalp diseases (eg eczema, skin lesions); (2) previous intracranial surgery, metal inside the head (outside the mouth) such as debris, surgical clips; Heart pacemaker, VNS, cochlear implant; (4) recurrent or severe headaches; (5) previous head injury and other brain-related diseases; and (6) pregnancy and breastfeeding.
Intervention groups
Group one : Ten participants (experimental group) receive anodic stimulation in a 2 mA current for 30 minutes for 10 consecutive days on the epileptogenic area, which is localized by long-term video-ECG monitoring. Group two : In ten patients for sham stimulation, the electrodes are placed in exactly the same position as the active stimulation on the scalp and the patient receives stimulation for only 60 seconds. However, the electrodes remain in place for 30 minutes. . The flow increases slowly in the first 15 seconds and decreases slowly in the last 15 seconds. Patients develop a sense of pruritus and murmur, but receive no flow for the remaining 29 minutes.
Main outcome variables
Change in hospital admission duration in epilepsy monitoring unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200111046082N2
Registration date:2020-04-10, 1399/01/22
Registration timing:prospective
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Soheila Rezakhani jafarabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 4196
Email address
drrezakhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of High Definition anodal transcranial direct current stimulation in shortening of duration of hospitalization in Epilepsy Monitoring Unit of patients with drug-resistant epilepsy
Public title
Determining the Efficacy of Brain Electrical Stimulation in Shortening the Hospitalization of Patients With drug resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with drug-resistant epilepsy as defined by the International League against epilepsy (ILAE)
Over 18 years old
In all patients, the probable epileptogenic zone is localized according to the epilepsy semiology and consecutive previous EEGs, and epileptogenic lesions are diagnosed by brain MRI with epilepsy protocol.
Exclusion criteria:
Under 18 years old
generalized epilepsy
scalp diseases such as eczema , cutaneous lesions ,
previous intracranial surgery
previous intracranial surgery, intracranial metal (out of mouth) such as tracking, surgical clip
implanted device such as cardiac pace maker, VNS, cochlear implant
severe and recurrent headaches
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were randomly divided into two groups of 20 each. Randomization was performed using random sequencing with the help of SAS statistical software. Patients were divided into treatment and control groups according to the order of entry based on this sequence. Sealed envelopes were used to hide random allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, main investigator and data analyser were masked of patients allocation. patients did not know the name of group and treatments. we used Sham for patients in control group. all questionnaire completed in different periods without name and only the related nurse know the patients allocations.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman university of Medical Sciences
Street address
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
IR.KMU.REC.1398.194
Health conditions studied
1
Description of health condition studied
drug resistant epilepsy
ICD-10 code
G40.21
ICD-10 code description
Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable
Primary outcomes
1
Description
Investigating changes in hospitalization duration in epilepsy monitoring unit
Timepoint
The frequency of epileptic seizures will be recorded in both groups for 7 days.
Method of measurement
Record the number of attacks
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during hospitalization in the EMU. Participants are randomly assigned to the experimental or sham group. Ten participants (experimental group) performed HD a-tDCS intervention in a current of 2 mA to fashion. They receive 30 minutes on the second day of hospitalization in the EMU twice in 4 hours on the epileptogenic zone.
Category
Treatment - Devices
2
Description
Control group: Twenty patients diagnosed with drug-resistant epilepsy will be studied according to the definition of the International league against Epilepsy (ILAE) after approval by the Ethics and Signature of consent. In all patients with possible epileptogenic zone according to semiology. The patient's previous epilepsy and lumbar strips are localized, and epileptogenic lesions are diagnosed by MRI of the brain with epilepsy protocols. Their antiepileptic drugs are discontinued during the hospitalization period in the EMU. Ten people (sham group) receive sham tDCS using the same position of the electrode.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Besat
Full name of responsible person
Soheila Rezakhani
Street address
Besat clinic, Doctor Bahonar hospital, 6th Gharanee Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
drrezakhani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Soheila Rezakhani Jafarabadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Vice-challenger of Research, Ebn-e sina St., Jahad blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
drrezakhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Soheila Rezakhani Jafarabadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Kerman Neuroscience Research Center, Ebn Sina st., Jehad Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
drrezakhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Soheila Rezakhani Jafarabadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Kerman Neuroscience Research Center, Ebn Sina st., Jehad Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Email
drrezakhani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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