Determining the efficacy of brain stimulation in improving patients with drug-resistant 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
patients with drug resistant epilepsy over 18 years of age that were not good candidate for epilepsy surgery or waiting for this type of surgery
Intervention groups
Group one : Ten participants (experimental group) receive cathodic stimulation in a 2 mA current for 30 minutes for 10 consecutive days on the epipeptogenic 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
Reduction of epileptic seizures in patients with drug resistant epilepsy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200111046082N1
Registration date:2020-04-03, 1399/01/15
Registration timing:retrospective
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
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
2018-05-05, 1397/02/15
Expected recruitment end date
2019-05-31, 1398/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy assessment of high definition cathodal transcranial direct current stimulation in treatment of patients with drug-resistant epilepsy
Public title
The assessment efficacy of electrical brain stimulation among patients with drug-resistant epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age>=18 y/o
all of patients full filled ILAE criteria of drug-resistant epilepsy
participants were not good candidate for epilepsy surgery and or they will not surgery or they waited for epilepsy surgery.
obtaining signed consent
Exclusion criteria:
scalp diseases(such as eczema, skin lesions)
previous intracranial surgery, intracranial metal (out of mouth) such as cracking, surgical clip
implanted device such as cardiac pacemaker, VNS, Cochlear implantation
recurrent or severe headaches
previous head trauma and other related brain diseases
pregnancy and lactation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients randomly divided in two groups (20 patients in each group) using random allocation sequence with SAS statistical software. according to this method a simple randomization list product and patients`involvement in each group determine base on order entry. we used sequentially numbered, sealed opaque envelopes for allocation concealment. patients (individuals) were the randomization units.
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
2018-08-13, 1397/05/22
Ethics committee reference number
IR.KMU.REC.1397.191
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 the frequency of epileptic seizures
Timepoint
before intervention and monthly for 3 months
Method of measurement
seizure diary
2
Description
Investigating the frequency changes of interictal epileptiform discharges
Timepoint
immediately before and after intervention and then monthly for 3 months
Method of measurement
30 minutes standard EEG
3
Description
side effects
Timepoint
immediately after stimulation
Method of measurement
specialist visit
4
Description
quality of life
Timepoint
before intervention and after 3 months
Method of measurement
full filling of the QoL in Epilepsy Inventory-89
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants are randomly assigned to an experimental or sham group. Ten participants (experimental group) received HD c-tDCS intervention in a 2 mA current for 30 minutes for 10 consecutive days over the epileptogenic zone. The standard 30-min brain tape will be administered in two groups immediately before and after the first and monthly stimulation for three months. Patients will also be tracked by the cigarette calendar. The frequencies of the intraectal epiglottis signals and waves before and after HD C-TDCS will be compared statistically. Quality of life (QoL) of patients will be assessed by QoL-Epilepsy Questionnaire -89 before the intervention and after three months. After each session of stimulation, side effects will be questioned and recorded.
Category
Treatment - Devices
2
Description
Control group: Patients with drug-resistant epilepsy who are not good candidates for epilepsy surgery or who do not want surgery or are waiting for surgery. In all patients, the epileptogenic zone is localized during prolonged EEG video-EEG monitoring, and epileptogenic lesions are diagnosed by brain epilepsy with epilepsy protocol. Their antiepileptic drugs did not change during the study period. Participants were randomly assigned to the experimental or sham group. In ten patients for sham stimulation, the electrodes were placed in exactly the same position as the active stimulation on the scalp and the patient received stimulation for only 60 seconds. The remaining 30 minutes remain in place. 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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Besat
Full name of responsible person
Soheila Rezakhani Jafar abadi
Street address
Gharanee St., Doctor Bahonar hospital, Besat clinic
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?
No
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
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
Krman 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
Krman 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
Not applicable
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