Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404691765975 Date of Approval: 10/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of transcranial direct current stimulation on drug-resistant temporal lobe epilepsy
Official scientific title The effect of transcranial direct current stimulation on drug resistant temporal lobe epilepsy
Brief summary describing the background and objectives of the trial Temporal lobe epilepsy (TLE) is the most common type of focal epilepsy that is difficult to treat, and often targeted for epilepsy surgery. Cathodal transcranial direct current stimulation is a non-invasive neuromodulation technique that has shown potential in reducing cortical excitability. The aim of this study is to investigate the impact of cathodal transcranial direct current polarization on temporal lobe drug-resistant epilepsy patients as assessed by seizure frequency, Liverpool seizure severity scale, and electroencephalography.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 01/09/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group sham stimulation Once daily split session (20minute stimulation- break for 20 min- repeat 20-minute stimulation) at 0mA intensity. 5 consecutive days Sham stimulation. The device was switched off a few seconds after reaching the target current intensity. 15 Placebo
Experimental Group Cathodal transcranial direct current stimulation Once daily split session (20minute stimulation- break for 20 min- repeat 20-minute stimulation) at 1mA intensity. 5 consecutive days Once daily split session (20minute stimulation- break for 20 min- repeat 20-minute stimulation) on 5 consecutive days of cathodal transcranial direct current stimulation at 1mA intensity. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Temporal lobe epilepsy patients ages range from 12 up to 40 years, are on two or more correctly prescribed tolerable antiepileptic drugs for more than 12 months with seizure frequency at least four per month. Patients and/or one of their relatives must be cooperative and be able to record the seizure severity and frequency. - Temporal lobe drug-resistant epileptic patients with a documented history of psychogenic non-epileptic seizures (PNES). - Temporal lobe drug-resistant epileptic patients and having other types of seizures. - Temporal lobe drug-resistant epileptic patients with failed surgical operations. - Temporal lobe drug-resistant epilepsy patients joining other scientific clinical trials. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 12 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/11/2020 Cairo University Faculty of Medicine Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Al-Saraya Street, AlManial Cairo 11562 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/03/2020 National Research Centre Medical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Al Buhouth st. Dokki Cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of the seizure frequency and seizure severity. Baseline and one month after baseline
Primary Outcome Number of epochs containing epileptiform discharges in the 1-hour EEG Baseline and one month after baseline
Secondary Outcome Difference between the mesial and lateral temporal lobe epilepsy regarding effect of cathodal transcranial direct current stimulation One month after baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Epilepsy Unit Kasr Alainy Hospital Al-Saraya street, AlManial Cairo Egypt
Clinical Neurophysiology Unit Kasr AlAiny Hospital Al-Saraya Street, AlManial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Cairo Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self funded Cairo Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Elnakah dr.elnakah@gmail.com +201270362263 11 Bab el Louk Sq. Abdeen
City Postal code Country Position/Affiliation
Cairo 11111 Egypt Assistant researcher of Clinical Neurophysiology National Research Centre
Role Name Email Phone Street address
Public Enquiries Eman El Zamarany emanzamarany2@gmail.com +201063584548 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Clinical Neurophysiology Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Nirmeen Kishk nirmeenkishk@kasralainy.edu.eg +201001128585 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Neurology Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the analyzable individual participant data collected during the trial after deidentification will be available starting 6 months from publication. Informed Consent Form,Study Protocol Starting 6 months after publication Researchers who provide a methodologically sound proposal. Proposals should be directed to the principal investigator's email to gain access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/03/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/03/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information