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

December 11, 2022 updated by: Onan Güren, Izmir Katip Celebi University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  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?

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
(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 Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
(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)
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.
(1) Baseline, (2) At the end of the last session of the intervention (immediately after the 10th session, each session is 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Onan Guren, PhD, İzmir Katip Çelebi University
  • Study Director: Ayhan Askin, MD, İzmir Katip Çelebi University
  • Principal Investigator: Ilker Sengul, MD, İzmir Katip Çelebi University
  • Principal Investigator: Mehmet Akif Ozdemir, PhD Cand., İzmir Katip Çelebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

October 15, 2023

Study Completion (Anticipated)

April 15, 2024

Study Registration Dates

First Submitted

November 26, 2022

First Submitted That Met QC Criteria

December 11, 2022

First Posted (Actual)

December 20, 2022

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-KAE-0017
  • 120E512 (Other Grant/Funding Number: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKEY)
  • 2022-TDR-MÜMF-0014 (Other Grant/Funding Number: IKCU Scientific Research Projects Coordination Unit)
  • 2021-ÖDL-MÜMF-0004 (Other Grant/Funding Number: IKCU Scientific Research Projects Coordination Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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