StrokeEEG-rTMSNCT05657392
Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) and 32 electrode electroencephalography (EEG) in people with Stroke and Stroke, Ischemic, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Quantitative EEG (qEEG) has been used as an effective tool in the diagnosis and prognosis of brain-related diseases. In the literature, a variety of qEEG parameters have been proven informative in the prognosis of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke/Brain Attack
- What is being tested?
- repetitive Transcranial Magnetic Stimulation (rTMS) and 32 electrode electroencephalography (EEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than age of 18 years.
- 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.
Who cannot join
- Presence of a clinical condition (metallic implant, cardiac or brain pace, claustrophobia, head trauma, cranial operation history) that may constitute a contraindication to repetitive transcranial magnetic stimulation intervention.
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ayhan Askin, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir Katip Celebi University
Izmir, Cigli, 35620
Onan Guren, PhD, +90 533 646 25 83, onan.guren@gmail.com
Ayhan Askin, MD, ayhanaskin@hotmail.com
About this study
Official title: Examination of Changes in Quantitative EEG Parameters Based on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Post Stroke
Quantitative EEG (qEEG) has been used as an effective tool in the diagnosis and prognosis of brain-related diseases. In the literature, a variety of qEEG parameters have been proven informative in the prognosis of stroke. In addition, it has been demonstrated that changes in certain qEEG parameters during traditional/task-specific rehabilitation approaches are correlated with clinical outcomes of functional motor recovery. Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a non-invasive and therapeutic treatment used to accelerate and enhance the recovery process of motor function in stroke patients. Many studies have reported that inhibiting contralesional rTMS may have positive effects in stroke patients with severe upper extremity motor impairment. In this context, the aim of the proposed study is to investigate whether there is a correlation between the change in qEEG parameters and the improvement of motor functions associated with rTMS treatment and to provide an electrophysiological prognostic biomarker of inhibiting contralesional rTMS for stroke patients.
Read the detailed description
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:
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:
- 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?
- Can the clinical response to rTMS be estimated from the quantitative EEG parameters calculated from just before rTMS application?
- Can electrophysiological effect of rTMS be observed from EEG measurements throughout the application?
- Conditions
- Stroke, Stroke, Ischemic, Stroke/Brain Attack
- Being tested
- repetitive Transcranial Magnetic Stimulation (rTMS), 32 electrode electroencephalography (EEG)
- Keywords
- Post Stroke, Repetitive Transcranial Magnetic Stimulation, Motor Recovery, quantitative EEG, Electroencephalogram, biomarkers
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic Stimulation (rTMS)Device
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)Other
32-electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting
| Study group | Role | What they receive |
|---|---|---|
| Inhibitory repetitive Transcranial Magnetic Stimulation | Experimental | 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. Receives: Device: repetitive Transcranial Magnetic Stimulation (rTMS); Other: 32 electrode electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a clinical stroke-specific scale that an assesment sensorimotor impairment. It is a powerful index applied clinically and also in research to identify the stroke severity, determine the motor recovery and to plan the rTMS interventions.
Measured: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
Secondary outcomes (2)
Change in Modified Ashworth Scale
The modified Ashworth Scale is a clinical index that used for assessment of muscle tone and evaluates the resistance occuring during passive range of motion.
Measured: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
Change in Brunnstrom Stages of Stroke Recovery
The Brunnstrom stages are a clinical scale that describe the changes in the ability of movement and the development and reorganization of brain at the post-stroke stage.
Measured: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start15 Apr 2021
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Onan Güren, Izmir Katip Celebi University
- Investigators
- Onan Guren, PhD, Principal investigator, Izmir Katip Celebi UniversityAyhan Askin, MD, Study director, Izmir Katip Celebi UniversityIlker Sengul, MD, Principal investigator, Izmir Katip Celebi UniversityMehmet Akif Ozdemir, PhD Cand., Principal investigator, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657392
- Sponsor's protocol ID
- 2020-KAE-0017
- Other IDs
- 120E512, 2022-TDR-MÜMF-0014, 2021-ÖDL-MÜMF-0004
- Acronym
- EEG-rTMS
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication All individual (confidential) data including clinical outcomes, demographic and clinical surveys, EEG measurements, MRI data, etc.
Publications
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.
PubMed 30910725Bembenek 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.
PubMed 23158578Bohannon 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.
PubMed 3809245Byblow 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.
PubMed 26150318Claflin ES, Krishnan C, Khot SP. Emerging treatments for motor rehabilitation after stroke. Neurohospitalist. 2015 Apr;5(2):77-88. doi: 10.1177/1941874414561023.
PubMed 25829989Conforto 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.
PubMed 22173953Coupar 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.
PubMed 22023891Finnigan 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.
PubMed 15001786Finnigan 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.
PubMed 26251106Fugl-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.
PubMed 1135616Griskova 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.
PubMed 17478041Kobayashi 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.
PubMed 12849236Langhorne 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.
PubMed 19608100Nowak 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.
PubMed 19531606Wagner 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.
PubMed 17444810
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Changes in Quantitative EEG Parameters Based on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Post Stroke
- ClinicalTrials.gov ID
- NCT05657392
- Acronym / sponsor ID
- EEG-rTMS / 2020-KAE-0017
- Conditions
- Stroke, Stroke, Ischemic, Stroke/Brain Attack
- Keywords
- Post Stroke, Repetitive Transcranial Magnetic Stimulation, Motor Recovery, quantitative EEG, Electroencephalogram, biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quantitative EEG (qEEG) has been used as an effective tool in the diagnosis and prognosis of brain-related diseases. In the literature, a variety of qEEG parameters have been proven informative in the prognosis of stroke. In addition, it has been demonstrated that changes in certain qEEG parameters during traditional/task-specific rehabilitation approaches are correlated with clinical outcomes of functional motor recovery. Repetitive transcranial magnetic stimulation (rTMS) has been proposed as a non-invasive and therapeutic treatment used to accelerate and enhance the recovery process of motor function in stroke patients. Many studies have reported that inhibiting contralesional rTMS may have positive effects in stroke patients with severe upper extremity motor impairment. In this context, the aim of the proposed study is to investigate whether there is a correlation between the change in qEEG parameters and the improvement of motor functions associated with rTMS treatment and to provide an electrophysiological prognostic biomarker of inhibiting contralesional rTMS for stroke patients.
Detailed description
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:
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:
- 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?
- Can the clinical response to rTMS be estimated from the quantitative EEG parameters calculated from just before rTMS application?
- Can electrophysiological effect of rTMS be observed from EEG measurements throughout the application?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhibitory repetitive Transcranial Magnetic Stimulation | Experimental | Device: repetitive Transcranial Magnetic Stimulation (rTMS), Other: 32 electrode electroencephalography (EEG)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than age of 18 years.
- 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.
Key exclusion criteria (12 listed)
- Presence of a clinical condition (metallic implant, cardiac or brain pace, claustrophobia, head trauma, cranial operation history) that may constitute a contraindication to repetitive transcranial magnetic stimulation intervention.
- Presence of malignancy or systemic rheumatic disease
- Pregnancy or breastfeeding
- Non-stroke disease or lesion affecting the sensorimotor system
- Alcohol or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Inhibitory repetitive Transcranial Magnetic Stimulation |
| 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 | Other | Inhibitory repetitive Transcranial Magnetic Stimulation |
Primary outcome
Change in The Fugl-Meyer Assessment (FMA)
Time frame: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
The Fugl-Meyer Assessment (FMA) is a clinical stroke-specific scale that an assesment sensorimotor impairment. It is a powerful index applied clinically and also in research to identify the stroke severity, determine the motor recovery and to plan the rTMS interventions.
2 secondary outcomes
Change in Modified Ashworth Scale
Time frame: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
Change in Brunnstrom Stages of Stroke Recovery
Time frame: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 30910725Alekseichuk 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.
- Background: PubMed 23158578Bembenek 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.
- Background: PubMed 3809245Bohannon 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.
- Background: PubMed 26150318Byblow 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.
- Background: PubMed 25829989Claflin ES, Krishnan C, Khot SP. Emerging treatments for motor rehabilitation after stroke. Neurohospitalist. 2015 Apr;5(2):77-88. doi: 10.1177/1941874414561023.
- Background: PubMed 22173953Conforto 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.
- Background: PubMed 22023891Coupar 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.
- Background: PubMed 15001786Finnigan 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.
- Background: PubMed 26251106Finnigan 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.
- Background: PubMed 1135616Fugl-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.
- Background: PubMed 17478041Griskova 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.
- Background: PubMed 12849236Kobayashi 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.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication All individual (confidential) data including clinical outcomes, demographic and clinical surveys, EEG measurements, MRI data, etc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayhan Askin, MD contact
Onan Guren, PhD principal investigator
Izmir Katip Celebi University
Ayhan Askin, MD study director
Izmir Katip Celebi University
Ilker Sengul, MD principal investigator
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation (rTMS) and 32 electrode electroencephalography (EEG) in people with Stroke and Stroke, Ischemic, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Onan Guren, PhD (+905336462583, onan.guren@ikc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The Fugl-Meyer Assessment (FMA) (time frame: (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657392, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.