NCT07250464

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

cortical silent periodmigrainesingle motor unittranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Single session measurement during TMS

Secondary Outcomes (1)

  • Motor Evoked Potential (MEP) Amplitude

    Single session measurement during TMS

Other Outcomes (2)

  • Correlation Between Neurophysiological Parameters and Disease Duration

    Single session measurement during TMS

  • Single Motor Unit (SMU) Firing Rate

    Single session measurement during TMS

Study Arms (2)

Migraine Patients

EXPERIMENTAL

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

Healthy Controls

SHAM COMPARATOR

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

Interventions

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.

Migraine Patients

Bipolar Ag/AgCl electrodes placed over the first dorsal interosseous (FDI) muscle to record muscle responses to TMS.

Healthy ControlsMigraine Patients

Sterile Teflon-coated needle electrodes inserted into the FDI muscle to record activity of individual motor units during TMS and voluntary contractions.

Healthy ControlsMigraine Patients

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45 years.
  • Right-handed individuals.
  • Migraine patients: diagnosed according to International Headache Society (IHS) criteria.
  • Healthy controls: no history of migraine or other neurological disorders.
  • Able and willing to provide informed consent.

You may not qualify if:

  • History of epilepsy or other seizure disorders.
  • Presence of metal implants, pacemakers, or other contraindications to TMS.
  • Pregnancy or breastfeeding.
  • History of significant neurological or psychiatric disorders.
  • Use of medications that significantly alter cortical excitability (e.g., antiepileptics, benzodiazepines) in the last 2 weeks.
  • Any musculoskeletal condition preventing safe participation in EMG/TMS procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gelisim University, Faculty of Dentistry, Translational Dentistry Research Laboratory

Istanbul, Istanbul, 34310, Turkey (Türkiye)

Location

Related Publications (5)

  • Haavik H, Niazi IK, Jochumsen M, Ugincius P, Sebik O, Yilmaz G, Navid MS, Ozyurt MG, Turker KS. Chiropractic spinal manipulation alters TMS induced I-wave excitability and shortens the cortical silent period. J Electromyogr Kinesiol. 2018 Oct;42:24-35. doi: 10.1016/j.jelekin.2018.06.010. Epub 2018 Jun 19.

    PMID: 29936314BACKGROUND
  • Ozyurt MG, Haavik H, Nedergaard RW, Topkara B, Senocak BS, Goztepe MB, Niazi IK, Turker KS. Transcranial magnetic stimulation induced early silent period and rebound activity re-examined. PLoS One. 2019 Dec 4;14(12):e0225535. doi: 10.1371/journal.pone.0225535. eCollection 2019.

    PMID: 31800618BACKGROUND
  • Todd G, Rogasch NC, Turker KS. Transcranial magnetic stimulation and peristimulus frequencygram. Clin Neurophysiol. 2012 May;123(5):1002-9. doi: 10.1016/j.clinph.2011.09.019. Epub 2011 Oct 22.

    PMID: 22019353BACKGROUND
  • Haavik, H., Özyurt, M. G., Niazi, I. K., Nedergaard, R. W., Topkara, B., Yilmaz, G., & Türker, K. S. (2018). Re-investigation on the nature and sign of transcranial magnetic stimulation-induced cortical silent period. In 11th Biennial Meeting of the International Motoneuron Society, IBS, 11-14 June 2018, Boulder, CO, USA (pp. 28-29). Article 46 https://motoneuron2018.org/wp-content/uploads/2018/05/IMS-Poster-Abstracts-2018.pdf

    BACKGROUND
  • Kahya MC, Yavuz SU, Turker KS. Cutaneous silent period in human FDI motor units. Exp Brain Res. 2010 Sep;205(4):455-63. doi: 10.1007/s00221-010-2380-6. Epub 2010 Aug 8.

    PMID: 20694723BACKGROUND

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Magnetic StimulationElectromyography

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Kemal Sıtkı Türker, Prof. Dr.

    Istanbul Gelisim University, Faculty of Dentistry, Translational Dentistry Research Laboratory

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemal Sıtkı Türker, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and responsible investigators do not know group assignments. Only the technical staff performing TMS and EMG recordings are aware of group allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two groups (migraine patients and healthy controls) are evaluated in parallel. Participants and the responsible investigators are blinded to group assignments to reduce bias. Only the staff performing TMS and EMG measurements are aware of group allocation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 26, 2025

Study Start

December 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (EMG and TMS measurements) will not be shared outside of the published study results to protect participant confidentiality and privacy.

Locations