Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)
NCT ID: NCT05657392
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-04-15
2024-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main questions it aims to answer are:
50 stroke patients will receive inhibiting contralesional rTMS at 1 Hz frequency. Upper extremity motor functions will be assessed with Fugl-Meyer Assessment-Upper Extremities (FMA-UE), Brunnstrom stages, modified Ashworth Scale (MAS) before and after treatment. The resting-state EEGs will be measured six time during the course of the treatment (Before/After 1. Session, Before/After 5. Session, Before/After 10. Session (end of the treatment)).
The main questions it aims to answer are:
1. How do the previously suggested quantitative EEG parameters (decrease in DAR (Delta Alpha power ratio), BSI (Brain Symmetry Index) and DTAB (Delta-theta to alpha-beta ratio, increase in alpha mean frequency ) change with rTMS application for the recovery of motor functions in patients with stroke and can they be defined as an effective biomarker for stroke treatment with rTMS?
2. Can the clinical response to rTMS be estimated from the quantitative EEG parameters calculated from just before rTMS application?
3. Can electrophysiological effect of rTMS be observed from EEG measurements throughout the application?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inhibitory repetitive Transcranial Magnetic Stimulation
All patients will receive inhibitory repetitive transcranial magnetic stimulation (rTMS) treatment at 1 Hz frequency. The contralesional primary motor cortex region will be stimulated with a Neurosoft-Neuro MS/D device. There will be a total of 10 treatment sessions over a 2-week period. Before each intervention, the resting motor threshold (rMT) value will be determined. rMT will be detected by obtaining a motor-evoked potential of \>50 μV amplitude on EMG recording of the contralateral first dorsal interosseous muscle in at least 5 out of 10 stimulations to the primary motor cortex. 90% of the motor threshold will be set in the stimulation. Each stimulation is planned for a total of 20 minutes and a total of 1200 pulses in the form of 1 Hz stimulation.
repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment. Last few decades, it has been revealed that rTMS accelerates motor recovery and may reduce stroke-related symptoms.
32 electrode electroencephalography (EEG)
32-electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
repetitive Transcranial Magnetic Stimulation (rTMS)
Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment. Last few decades, it has been revealed that rTMS accelerates motor recovery and may reduce stroke-related symptoms.
32 electrode electroencephalography (EEG)
32-electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of ischemic or hemorrhagic stroke confirmed by MRI.
* Having a stroke for the first time.
* Patients who agreed to participate by signing the informed consent form.
Exclusion Criteria
* Presence of malignancy or systemic rheumatic disease
* Pregnancy or breastfeeding
* Non-stroke disease or lesion affecting the sensorimotor system
* Alcohol or drug addiction
* Presence of pump/shunt
* Presence of severe cognitive impairment
* Presence of \>3 spasticity in the upper extremity defined according to the Modified Ashworth Scale
* History of psychiatric illness such as major depression/personality disorders
* History of epilepsy or taking medication due to epilepsy
* Diagnosed with dementia
* Received rTMS intervention before
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Scientific and Technological Research Council of Turkey
OTHER
Izmir Katip Celebi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Onan Güren
Asst. Prof. Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Onan Guren, PhD
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
Ayhan Askin, MD
Role: STUDY_DIRECTOR
Izmir Katip Celebi University
Ilker Sengul, MD
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
Mehmet Akif Ozdemir, PhD Cand.
Role: PRINCIPAL_INVESTIGATOR
Izmir Katip Celebi University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Izmir Katip Celebi University
Izmir, Cigli, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Onan Guren, PhD
Role: primary
Ayhan Askin, MD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Byblow WD, Stinear CM, Barber PA, Petoe MA, Ackerley SJ. Proportional recovery after stroke depends on corticomotor integrity. Ann Neurol. 2015 Dec;78(6):848-59. doi: 10.1002/ana.24472. Epub 2015 Nov 17.
Claflin ES, Krishnan C, Khot SP. Emerging treatments for motor rehabilitation after stroke. Neurohospitalist. 2015 Apr;5(2):77-88. doi: 10.1177/1941874414561023.
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Alekseichuk I, Mantell K, Shirinpour S, Opitz A. Comparative modeling of transcranial magnetic and electric stimulation in mouse, monkey, and human. Neuroimage. 2019 Jul 1;194:136-148. doi: 10.1016/j.neuroimage.2019.03.044. Epub 2019 Mar 22.
Bembenek JP, Kurczych K, Karli Nski M, Czlonkowska A. The prognostic value of motor-evoked potentials in motor recovery and functional outcome after stroke - a systematic review of the literature. Funct Neurol. 2012 Apr-Jun;27(2):79-84.
Conforto AB, Anjos SM, Saposnik G, Mello EA, Nagaya EM, Santos W Jr, Ferreiro KN, Melo ES, Reis FI, Scaff M, Cohen LG. Transcranial magnetic stimulation in mild to severe hemiparesis early after stroke: a proof of principle and novel approach to improve motor function. J Neurol. 2012 Jul;259(7):1399-405. doi: 10.1007/s00415-011-6364-7. Epub 2011 Dec 16.
Coupar F, Pollock A, Rowe P, Weir C, Langhorne P. Predictors of upper limb recovery after stroke: a systematic review and meta-analysis. Clin Rehabil. 2012 Apr;26(4):291-313. doi: 10.1177/0269215511420305. Epub 2011 Oct 24.
Finnigan SP, Rose SE, Walsh M, Griffin M, Janke AL, McMahon KL, Gillies R, Strudwick MW, Pettigrew CM, Semple J, Brown J, Brown P, Chalk JB. Correlation of quantitative EEG in acute ischemic stroke with 30-day NIHSS score: comparison with diffusion and perfusion MRI. Stroke. 2004 Apr;35(4):899-903. doi: 10.1161/01.STR.0000122622.73916.d2. Epub 2004 Mar 4.
Finnigan S, Wong A, Read S. Defining abnormal slow EEG activity in acute ischaemic stroke: Delta/alpha ratio as an optimal QEEG index. Clin Neurophysiol. 2016 Feb;127(2):1452-1459. doi: 10.1016/j.clinph.2015.07.014. Epub 2015 Jul 22.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Griskova I, Ruksenas O, Dapsys K, Herpertz S, Hoppner J. The effects of 10 Hz repetitive transcranial magnetic stimulation on resting EEG power spectrum in healthy subjects. Neurosci Lett. 2007 May 29;419(2):162-7. doi: 10.1016/j.neulet.2007.04.030. Epub 2007 Apr 18.
Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.
Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
Nowak DA, Grefkes C, Ameli M, Fink GR. Interhemispheric competition after stroke: brain stimulation to enhance recovery of function of the affected hand. Neurorehabil Neural Repair. 2009 Sep;23(7):641-56. doi: 10.1177/1545968309336661. Epub 2009 Jun 16.
Wagner T, Valero-Cabre A, Pascual-Leone A. Noninvasive human brain stimulation. Annu Rev Biomed Eng. 2007;9:527-65. doi: 10.1146/annurev.bioeng.9.061206.133100.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
120E512
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022-TDR-MÜMF-0014
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021-ÖDL-MÜMF-0004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2020-KAE-0017
Identifier Type: -
Identifier Source: org_study_id