Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)

NCT05657392 | Unknown

• 4 other identifiers: 2020-KAE-0017120E5122022-TDR-MÜMF-00142021-ÖDL-MÜMF-0004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Stroke, Ischemic; Stroke/Brain Attack

Keywords

Post Stroke; Repetitive Transcranial Magnetic Stimulation; Motor Recovery; quantitative EEG; Electroencephalogram; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  (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

  (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

  (1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)

Study Arms (1)

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.

Device: repetitive Transcranial Magnetic Stimulation (rTMS); Other: 32 electrode electroencephalography (EEG)

Interventions

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.

Inhibitory repetitive Transcranial Magnetic Stimulation

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

Inhibitory repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Izmir Katip Celebi University

Izmir, Cigli, 35620, Turkey (Türkiye)

RECRUITING

Related Publications (15)

• 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.

  PMID: 30910725 BACKGROUND

• 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.

  PMID: 23158578 BACKGROUND

• 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.

  PMID: 3809245 BACKGROUND

• 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.

  PMID: 26150318 BACKGROUND

• Claflin ES, Krishnan C, Khot SP. Emerging treatments for motor rehabilitation after stroke. Neurohospitalist. 2015 Apr;5(2):77-88. doi: 10.1177/1941874414561023.

  PMID: 25829989 BACKGROUND

• 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.

  PMID: 22173953 BACKGROUND

• 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.

  PMID: 22023891 BACKGROUND

• 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.

  PMID: 15001786 BACKGROUND

• 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.

  PMID: 26251106 BACKGROUND

• 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.

  PMID: 1135616 BACKGROUND

• 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.

  PMID: 17478041 BACKGROUND

• 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.

  PMID: 12849236 BACKGROUND

• 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.

  PMID: 19608100 BACKGROUND

• 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.

  PMID: 19531606 BACKGROUND

• 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.

  PMID: 17444810 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Onan Guren, PhD

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

• Ayhan Askin, MD

  Izmir Katip Celebi University

  STUDY DIRECTOR

• Ilker Sengul, MD

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

• Mehmet Akif Ozdemir, PhD Cand.

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onan Guren, PhD

CONTACT

+905336462583; onan.guren@ikc.edu.tr

Ayhan Askin, MD

CONTACT

ayhanaskin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 20, 2022
• Study Start: April 15, 2021
• Primary Completion: October 15, 2023
• Study Completion: April 15, 2024
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: All IPD will be shared with a dataset article.
• Access Criteria: Will be announced.

Locations

TU (1)