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

Primary Purpose

Stroke, Stroke, Ischemic, Stroke/Brain Attack

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (rTMS)
32 electrode electroencephalography (EEG)
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Post Stroke, Repetitive Transcranial Magnetic Stimulation, Motor Recovery, quantitative EEG, Electroencephalogram, biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Izmir Katip Celebi UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhibitory repetitive Transcranial Magnetic Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 26, 2022
Last Updated
December 11, 2022
Sponsor
Izmir Katip Celebi University
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05657392
Brief Title
Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)
Acronym
EEG-rTMS
Official Title
Examination of Changes in Quantitative EEG Parameters Based on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke/Brain Attack
Keywords
Post Stroke, Repetitive Transcranial Magnetic Stimulation, Motor Recovery, quantitative EEG, Electroencephalogram, biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inhibitory repetitive Transcranial Magnetic Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
32 electrode electroencephalography (EEG)
Intervention Description
32-electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting
Primary Outcome Measure Information:
Title
Change in The Fugl-Meyer Assessment (FMA)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change in Modified Ashworth Scale
Description
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.
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)
Title
Change in Brunnstrom Stages of Stroke Recovery
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onan Guren, PhD
Phone
+905336462583
Email
onan.guren@ikc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Ayhan Askin, MD
Email
ayhanaskin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onan Guren, PhD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayhan Askin, MD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilker Sengul, MD
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Ozdemir, PhD Cand.
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Katip Celebi University
City
İzmir
State/Province
Cigli
ZIP/Postal Code
35620
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onan Guren, PhD
Phone
+90 533 646 25 83
Email
onan.guren@gmail.com
First Name & Middle Initial & Last Name & Degree
Ayhan Askin, MD
Email
ayhanaskin@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
All IPD will be shared with a dataset article.
IPD Sharing Access Criteria
Will be announced.
Citations:
PubMed Identifier
30910725
Citation
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Results Reference
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23158578
Citation
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Quantitative EEG Changes Following Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke (EEG-rTMS)

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