An interventional study of Transcranial Magnetic Stimulation (TMS) and Surface Electromyography (sEMG) in Migraine and Healty Controls, sponsored by Istanbul Gelisim University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Istanbul Gelisim University · Not applicable, Interventional, and Basic science
The primary objective of this study is to assess the level of inhibitory control in the motor cortex of migraine patients using objective and non-invasive methods. To this end, Motor Evoked Potential (MEP) and Cortical Silence Period (CSP) parameters obtained using Transcranial Magnetic Stimulation (TMS) will be measured and comparisons will be made between migraine patients and healthy controls. Since CSP duration is used specifically in the evaluation of GABA-B-mediated inhibitory mechanisms, it has the potential to directly measure the effect of migraine on cortical inhibition.
Rationale and Background:
Migraine is a neurological disorder that significantly impairs individual quality of life and imposes substantial economic burdens on healthcare systems worldwide. Although its pathophysiology is not fully understood, recent research suggests that migraine is associated not only with vascular changes but also with alterations at neurological and cortical levels (Goadsby et al., 2017). Evidence increasingly indicates enhanced excitability and disrupted inhibitory mechanisms in central nervous system regions, including the motor cortex (Coppola et al., 2007).
Transcranial Magnetic Stimulation (TMS) is a non-invasive and reliable neurophysiological technique that stimulates the motor cortex and records muscle responses. Parameters obtained through TMS, such as Motor Evoked Potential (MEP) and Cortical Silent Period (CSP), are used to assess cortical excitability and inhibitory control, respectively (Chen et al., 1999). CSP is particularly useful for evaluating GABA-B-mediated inhibitory mechanisms. The hypothesis that migraine patients exhibit reduced cortical inhibition can be directly tested using CSP measurements.
Previous studies have reported shortened CSP durations and increased MEP amplitudes in migraine patients, suggesting cortical hyperexcitability (Brighina et al., 2002; Afra et al., 1998). However, these findings are inconsistent, and how they vary across migraine subtypes (with aura vs. without aura) remains unclear. Therefore, this study aims to characterize cortical physiological changes in migraine using objective and quantitative measures, filling gaps in the literature and contributing to clinical evaluations. Additionally, the relationship of these parameters with clinical features such as migraine type, duration, and attack frequency will be investigated to lay the groundwork for individualized neurophysiological profiling.
Primary and Secondary Objectives:
Primary Objective:
The primary objective of this study is to objectively evaluate inhibitory control in the motor cortex of migraine patients using non-invasive methods. Motor Evoked Potentials (MEP) and Cortical Silent Periods (CSP) obtained through TMS will be measured and compared between migraine patients and healthy controls. CSP duration, reflecting GABA-B-mediated inhibitory mechanisms, allows direct assessment of migraine's effect on cortical inhibition (Chen et al., 1999).
Secondary Objectives:
Motor Output Analysis: Electromyographic (EMG) signals will be analyzed using Peristimulus Time Histogram (PSTH) and Peristimulus Frequencygram (PSF) methods to assess the temporal pattern and frequency changes of motor unit responses following TMS. PSTH analyzes the timing of individual motor units after stimulation, while PSF provides a more precise view of post-stimulation frequency changes (Türker \& Powers, 2001). These analyses help reveal the spinal reflection of cortical stimulation and its effect on motor output.
Biomarker Potential: TMS-derived parameters such as CSP and MEP will be evaluated for their potential as biomarkers of migraine pathophysiology, contributing to the development of objective measures for future diagnosis and treatment.
Expected Benefits:
At the end of this study, it is expected to obtain objective data on motor cortical inhibitory capacity in migraine patients. TMS parameters, particularly CSP and MEP, can be used to understand the neurophysiological basis of migraine. The results may provide:
Improved understanding of cortical excitability and inhibition balance in migraine pathophysiology.
Foundational data for the development of objective diagnostic biomarkers for migraine.
Evidence of cortical dysfunction in migraine patients, supporting personalized treatment approaches.
A comprehensive understanding of motor output from cortical to spinal levels via electrophysiological analyses (PSTH/PSF).
All procedures are non-invasive and safe, providing a reproducible and ethical research approach.
Study Methods:
Participants:
The study will include right-handed individuals aged 18-45 years with a prior diagnosis of migraine according to the International Headache Society (IHS) criteria.
Data Collection:
The study will use non-invasive brain stimulation (TMS) along with surface electromyography (sEMG) and needle EMG. Measurements will be performed both at rest and during voluntary muscle contraction. TMS will be applied over the motor cortex, and muscle responses will be recorded simultaneously using sEMG electrodes. For detailed motor neuron analysis, single motor unit (SMU) recordings will also be obtained.
Needle EMG/SMU Recording:
SMU recordings will use sterile, Teflon-coated needles containing copper wires (approximately 70 μm diameter, 25G) inserted into the first dorsal interosseous (FDI) muscle. Needles will be partially retracted to maintain electrode stability, allowing single motor unit activity to be recorded even during movement.
TMS Application:
TMS will be performed using a Magstim 200\^2 Monophasic Stimulator (Magstim Ltd, UK) with a 70 mm figure-of-eight coil placed over the dominant hemisphere's primary motor cortex (M1) corresponding to the FDI muscle. Resting Motor Threshold (RMT) will be determined, followed by stimulation to elicit MEPs.
Surface EMG Recording:
sEMG signals will be obtained using Ag/AgCl electrodes placed over the FDI muscle. Signals will be amplified with a CED 1902 amplifier and digitized via CED 3601 Power 1401 DAC unit. MEP latencies and amplitudes, as well as CSP durations, will be calculated. Participants will maintain \~20% maximal voluntary contraction during measurements.
Data Analysis:
Data will be analyzed using IBM SPSS Statistics 26. Normality will be tested using Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric data will be analyzed using independent t-tests and ANOVA, while non-parametric data will be analyzed with Mann-Whitney U or Kruskal-Wallis tests. Correlations between clinical parameters (migraine duration, frequency, severity) and neurophysiological measures (MEP, CSP) will be assessed using Pearson or Spearman correlation coefficients, with significance set at p \< 0.05.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Istanbul Gelisim University is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants aged 18-45 with a prior diagnosis of migraine according to IHS criteria. Transcranial Magnetic Stimulation (TMS) Surface Electromyography (sEMG) Needle EMG / Single Motor Unit (SMU) Recording
Other: Transcranial Magnetic Stimulation (TMS) · Device: Surface Electromyography (sEMG) · Other: Needle EMG / Single Motor Unit (SMU) Recording
Age- and sex-matched adults without a history of migraine or neurological disorders. They undergo the same sEMG and needle EMG/SMU procedures as the migraine group, but the TMS is sham. Surface Electromyography (sEMG) Needle EMG / Single Motor Unit (SMU) Recording Transcranial Magnetic Stimulation (TMS) SHAM
Device: Surface Electromyography (sEMG) · Other: Needle EMG / Single Motor Unit (SMU) Recording
Non-invasive brain stimulation applied to the primary motor cortex to elicit motor evoked potentials (MEP) and cortical silent periods (CSP). 70 mm figure-of-eight coil used with Magstim 200² Monophasic Stimulator.
Bipolar Ag/AgCl electrodes placed over the first dorsal interosseous (FDI) muscle to record muscle responses to TMS.
Sterile Teflon-coated needle electrodes inserted into the FDI muscle to record activity of individual motor units during TMS and voluntary contractions.
Cortical Silent Period (CSP) Duration
CSP duration will be recorded from the first dorsal interosseous (FDI) muscle using surface EMG during TMS. CSP reflects GABA-B-mediated cortical inhibitory mechanisms, allowing direct assessment of cortical inhibition in migraine patients compared to healthy controls.
Time frame: Single session measurement during TMS
Motor Evoked Potential (MEP) Amplitude
MEP amplitudes will be recorded from FDI muscle using surface EMG. Changes in MEP amplitude reflect cortical excitability and motor output.
Time frame: Single session measurement during TMS
Correlation Between Neurophysiological Parameters and Disease Duration
The relationship between TMS parameters (CSP duration, MEP amplitude) and the duration of the migraine disorder will be assessed using correlation analysis (Pearson or Spearman). Disease duration is determined based on the patient's medical history interview.
Time frame: Single session measurement during TMS
Single Motor Unit (SMU) Firing Rate
The discharge rate (firing frequency) of single motor units recorded from the first dorsal interosseous (FDI) muscle using needle EMG during voluntary contraction.
Time frame: Single session measurement during TMS
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (EMG and TMS measurements) will not be shared outside of the published study results to protect participant confidentiality and privacy.
Start is estimated for Dec 2025; primary completion for Jan 2026, 1 month later.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 1 month is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Istanbul Gelisim University