Evaluation of the effect of repetitive extracerebral magnetic stimulation (rTMS) in improving motor performanceand swallowing disorders in patients with ischemic stroke
To determine the effect of repetitive transcranial magnetic stimulation (rTMS) on motor and swallowing improvement in ischemic stroke patients
Design
Semi-experimental before–after study with one group (n=205). No randomization. Non-drug phase.
Settings and conduct
A semi-experimental before–after study conducted at the Rehabilitation Clinic of Jam Hospital. Eligible ischemic stroke patients will be enrolled after informed consent and receive rTMS sessions per standard protocol. Motor and swallowing functions are assessed before and after treatment. No blinding applied.
Participants/Inclusion and exclusion criteria
Inclusion: Confirmed ischemic stroke (CT/MRI), age 25–65, motor or swallowing deficit, ≥2 weeks post-stroke, stable, informed consent.
Exclusion: Hemorrhagic stroke, active epilepsy, metal implants, severe cognitive/psychiatric disorder, pregnancy, non-cooperation.
Intervention groups
All eligible ischemic stroke patients receive rTMS per protocol. Motor and swallowing functions are assessed by Fugl-Meyer and FOIS before and after treatment. No control group.
Main outcome variables
Change in Fugl-Meyer Motor Score; Change in Functional Oral Intake Scale before and after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251027067782N1
Registration date:2025-11-27, 1404/09/06
Registration timing:prospective
Last update:2025-11-27, 1404/09/06
Update count:0
Registration date
2025-11-27, 1404/09/06
Registrant information
Name
Amirali Akbari baghbaderani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
amiraliakbri1999@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-12-07, 1404/09/16
Expected recruitment end date
2026-07-22, 1405/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of repetitive extracerebral magnetic stimulation (rTMS) in improving motor performanceand swallowing disorders in patients with ischemic stroke
Public title
The effect of repetitive magnetic stimulation on movement and swallowing in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed ischemic stroke by CT or MRI
Presence of motor or swallowing dysfunction after stroke
At least two weeks post-stroke (clinically stable phase)
Ability to attend therapy sessions
Written informed consent obtained
Exclusion criteria:
Hemorrhagic stroke
History of epilepsy or active seizures
Metallic implants or contraindicated medical devices for rTMS
Severe psychiatric or cognitive disorders
Inability to cooperate in therapy sessions
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
205
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is a semi-experimental (before–after) design in which ischemic stroke patients are evaluated before and after receiving repetitive transcranial magnetic stimulation (rTMS) in terms of motor and swallowing function. Due to the therapeutic nature of the intervention and ethical and practical limitations in establishing a control group, a before–after design was chosen so that each patient serves as their own control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Ethics Committee of Islamic Azad University, Tehran Medical Sciences Branch
Street address
Tehran, Shahid Ghandi St., North of Sadr Bridge, Shariati St., Islamic Azad University, Tehran Medical Sciences Branch
City
Tehran
Province
Tehran
Postal code
1919893651
Approval date
2024-12-24, 1403/10/04
Ethics committee reference number
IR.IAU.TMU.REC.1403.356
Health conditions studied
1
Description of health condition studied
Ischemic Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Change in motor function score measured by the Fugl Meyer Assessment from before the intervention to after completion of the intervention
Timepoint
Measurement of motor function at baseline before the start of the intervention and after completion of the full course of repetitive transcranial magnetic stimulation sessions
Method of measurement
Motor function measurement using the Fugl Meyer Assessment administered by a trained rehabilitation specialist
2
Description
Change in swallowing function score measured by the Functional Oral Intake Scale from before the intervention to after completion of the intervention
Timepoint
Measurement of swallowing function at baseline before the start of the intervention and after completion of the full course of repetitive transcranial magnetic stimulation sessions
Method of measurement
Swallowing function measurement using the Functional Oral Intake Scale administered by a trained speech therapist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with ischemic stroke receive repetitive transcranial magnetic stimulation according to the standard protocol. The intervention consists of stimulation of the primary motor cortex of the affected hemisphere at a frequency of ten hertz, an intensity equal to one hundred percent of the motor threshold, a total of one thousand five hundred pulses per session, and an approximate duration of twenty minutes. Treatment sessions are delivered five times per week for two consecutive weeks. No additional intervention is applied during the treatment period.
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the sensitive nature of individual patient data in ischemic stroke populations and the substantial risk of re-identification even after de-identification procedures, the ethics committee has imposed specific restrictions on data sharing. To ensure maximum confidentiality and full compliance with ethical and legal requirements, the individual participant data from this study cannot be publicly shared at this time. No additional information is available.