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Evaluation of the efficacy of repetitive transcranial magnetic stimulation in the treatment of patients with functional neurological symptoms (psychological non-epileptic seizure subtype)

Protocol summary

Study aim
Determination of the Effectiveness of repetitive Transcranial Magnetic Stimulation(rTMS) on Psychological Non-Epileptic Seizure Symptoms, Symptoms of Depression, and Quality of Life in Patients with Functional Neurological Symptom Disorder ( Psychological Non-Epileptic Seizure subtype)
Design
This study is a randomized, placebo-controlled, double-blind, parallel-groups clinical trial.
Settings and conduct
Thirty patients with psychological nonepileptic seizures were selected from referrals to the neuropsychiatric clinic of Imam Khomeini Hospital in Tehran based on inclusion and exclusion criteria and referred to the rTMS center. In this center, patients are randomly divided into two groups of experimental and control. Patients, researchers, and data analysts are blind to the randomization. The therapeutic and simulated sessions were performed on the experimental and control groups, respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients over 18 years of age with non-epileptic seizure disorder Exclusion criteria: a history of seizures in the patient or his family, Use of seizure threshold lowering drugs, epileptiform changes in long-term electroencephalographic monitoring,suicidal ideation and recent suicidal attempt, psychosis, pregnancy, and metal objects within 30 cm of the coil
Intervention groups
The experimental group received 12 sessions of rTMS and the control group received 12 simulated sham rTMS sessions.
Main outcome variables
Changes in severity of epileptiform symptoms, depression and quality of life of experimental compared to control group

General information

Reason for update
Acronym
rTMS in PNES
IRCT registration information
IRCT registration number: IRCT20200225046611N1
Registration date: 2020-04-01, 1399/01/13
Registration timing: prospective

Last update: 2020-04-01, 1399/01/13
Update count: 0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Mohammad Arbabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2421
Email address
arbabimo@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2021-01-06, 1399/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of repetitive transcranial magnetic stimulation in the treatment of patients with functional neurological symptoms (psychological non-epileptic seizure subtype)
Public title
Repetitive transcranial magnetic stimulation in psychological non-epileptic seizure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with psychological non-epileptic seizure based on DSM5
Exclusion criteria:
True seizure or epileptiform changes in electroencephalographic long term monitoring Suicide thought Use of Lowering seizure threshold drugs Risk of new suicide attempt Psychosis Personal or family history of seizure Metal objects within 30 cm of the coil such as: aneurysm clips, cervical or cerebral stents, cardiac pacemaker or defibrillators, cochlear implants, Face tattoo using magnetic field sensitive ink
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization Randomization unit: individual Randomization instrument: random allocation software Random sequences using quadratic blocks Allocation concealment with software
Blinding (investigator's opinion)
Double blinded
Blinding description
After examining the inclusion and exclusion criteria, the researcher will refer patients to the rTMS unit. In this unit by the therapist, referral patients are divided into two groups of test and control using random numbers. Some receive rTMS treatment and some sham TMS. Intervention in control group designed the same as real treatment that means the patient is in a chair and the coil is placed on his head but magnetism wouldn't used. The evaluator who asks the patient the questionnaire questions before and after the intervention and the data analyzer will not know which patients are in the test or control group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.851

Health conditions studied

1

Description of health condition studied
Functional neurological symptom disorder (Psychogenic non-epileptic seizure subtype)
ICD-10 code
F44.4
ICD-10 code description
Conversion disorder with motor symptom or deficit

Primary outcomes

1

Description
Psychological non-epileptic seizures severity
Timepoint
At the beginning of the study (before the intervention), immediately after the intervention and two months later
Method of measurement
Clinical Global Impression

Secondary outcomes

1

Description
Depressive severity
Timepoint
At the beginning of study(before intervention), immediately after intervention and two months later
Method of measurement
Beck's depression inventory

2

Description
Quality of life
Timepoint
At the beginning of study(before intervention), immediately after intervention and two months later
Method of measurement
WHO Quality of Life-BREF

Intervention groups

1

Description
Intervention group: Stimulation with rTMS Variant 2 from NEROSOFT Russia company by 10 Hz frequency, 12 sessions for one month, 25 minutes per session, 1200 stimulations per day, with appropriate stimulation threshold for each individual using eight coils and over The right temporo-parietal junction will be performed.
Category
Treatment - Devices

2

Description
Control group: patients in this group sit on the rTMS chair for 12 months for 25 minutes but do not receive any magnetic stimulation.After completion of the study, the group will receive routine treatment if symptoms persist.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohammad Reza Shegarf Nakhaie
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Email
rezashegarf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Fax
+98 21 6670 6141
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
nimad
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Arbabi
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital Complex,Tehran Province ,Tehran Chamran, East, Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
14119733141
Phone
+98 21 6119 2421
Fax
Email
arbabimo@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Arbabi
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital Complex,Tehran Province ,Tehran Chamran, East, Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Fax
Email
arbabimo@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Arbabi
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital Complex,Tehran Province ,Tehran Chamran, East, Highway, Baqerkhan St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2421
Fax
Email
arbabimo@tums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
patients' data can be shared after unidentifiable and deleted names
When the data will become available and for how long
Access will begin 6 months after the results are published
To whom data/document is available
Data will be available only to researchers working in academic and scientific centers.
Under which criteria data/document could be used
Documentation is only available for meta-analysis studies
From where data/document is obtainable
Access information on request at arbabimo@tums.ac.ir
What processes are involved for a request to access data/document
Applicants must identify their scientific and academic identities and clearly state their intention to request information for use in meta-analytic research.
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