Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels

May 8, 2023 updated by: Kátia Monte-Silva, Universidade Federal de Pernambuco

Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels

This study aims to investigate if the size effect of repetitive magnetic transcranial stimulation in the paretic upper limb in patients after stroke is influenced by the therapeutic decision.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After the patients and volunteers signed an informed consent form they will be classified and randomized using a website (randomization.com) by a non-involved researcher.

All patients and volunteers will be assigned to groups (arms) after being tried:

(i) rTMS-DIR: in which the patients will be submitted to a customized treatment with repetitive transcranial magnetic stimulation (rTMS) based in neurophysiological assessments; (ii) rTMS: patients will be submitted to standard treatment in the lesioned or non-lesioned hemisphere based in neurophysiological assessments; (iii) rTMS sham: each patient will receive a sham intervention that emits the same sound as the real stimulation;

In each group, the patients will be submitted to 10 sessions for two weeks, five days a week in which will receive the rTMS followed by 45 minutes of neurofunctional physiotherapy. All outcomes will be assessed before and after the 10 sessions.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-560
        • Recruiting
        • Federal University of Pernambucano
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • More than 3 months after stroke;
  • Ischemic or hemorrhagic stroke with upper limb motor impairment;

Exclusion Criteria:

  • Any contraindication for application of transcranial magnetic stimulation;
  • Peripheral lesions in the assessed upper limb;
  • Score ≤ 18 at Folstein Mini Mental State Examination;
  • Alteration of drugs that alter the excitability of the cortex (in less than 3 months);
  • Application of botulinum toxin in less than 6 months.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMSc + physiotherapy
A conventional high-frequency rTMS (rTMSc) will be applied over the lesioned hemisphere over the motor cortex. After rTMSc, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
Device: rTMSc
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Behavioral: Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
Experimental: rTMSp + physiotherapy
A personalized high or low-frequency rTMS (rTMSp) will be applied to the lesioned or non-lesioned hemisphere depending on cortical biomarkers assessment guide a personalized stimulation for each patient in this group. After rTMSp, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
Device: rTMSc
In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
Behavioral: Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
Sham Comparator: tDCS sham + physiotherapy
The sham protocol will be delivered to each patient of this arm imitating the exat sound of the equipment and structure of the experimental arms. After rTMS sham, patients will be submitted to 45 minutes of neurofunctional physiotherapy. Experimental sessions will be repeated five times per week for two weeks.
Behavioral: Neurofunctional physiotherapy
All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
Device: rTMS sham
During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain symmetry (baseline)
Time Frame: Before each session (10 sessions for 5 days a week for two weeks)

Accessed with:

Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
Before each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (post-treatment)
Time Frame: After each session (10 sessions for 5 days a week for two weeks)

Accessed with:

Quantitative electroencephalogram (qEEG) through the power spectral density (PSD) for each channel considering each band frequency: delta (0,5 a ≤ 4 Hz); theta (> 4 a ≤ 8 Hz); alpha (> 8 a ≤13 Hz); beta (> 13 a ≤ 30 Hz); gama (< 30 a ≤ 45 Hz) and the relative power for each band. . The Brain Symmetry Index (BSI) will be used to assess the absolute value of the difference in mean hemispheric power in the frequency range of 1 to 45Hz. All of these measures derive from each qEEG band frequency.
After each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (baseline)
Time Frame: Before each session (10 sessions for 5 days a week for two weeks)

Accessed with:

Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
Before each session (10 sessions for 5 days a week for two weeks)
Brain symmetry (post-treatment)
Time Frame: After each session (10 sessions for 5 days a week for two weeks)

Accessed with:

Low-Resolution Brain Electromagnetic Tomography (LORETA) software. All data from qEEG will also be computed to the LORETA software to generate a tridimensional image of the patient's brain.
After each session (10 sessions for 5 days a week for two weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl Meyer assesment of paretic upper limb motor function
Time Frame: 10 sessions (5 days a week for two weeks)
Fugl Meyer assesment is used to measure motor control recovery. It is a 226 point scoring system that includes the following sessions: range of motion, pain, sensation,motor function of upper and lower limbs, balance, coordination and velocity. We will apply only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points. Higher scores indicates better outcomes
10 sessions (5 days a week for two weeks)
Modified Ashworth Scale
Time Frame: 10 sessions (5 days a week for two weeks)
The modified Ashworth scale is a 6-point rating scale that is used to measure muscle tone and it will be used to determine the spasticity wrist flexor muscles in the affected hand by stroke. It evaluates the antagonist muscles that limits the force of agonist muscled during a intended motion.
10 sessions (5 days a week for two weeks)
The National Institutes of Health Stroke
Time Frame: 10 sessions (5 days a week for two weeks)
This scale will determine the severity and disability level of the post-stroke patient; which consists of 15 items that assess the domains: level of consciousness, eye movements, visual field, facial movements, motor function and ataxia of upper and lower limbs, as well as sensitivity, language, presence of dysarthria and spatial neglect. Each domain punctuates a specific skill from 0 (zero) to 4 points that may vary until a maximum of 42 points.
10 sessions (5 days a week for two weeks)

Collaborators and Investigators

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

Sponsor

Universidade Federal de Pernambuco

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)

March 29, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS_biomarkers_stroke

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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