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

Universidade Federal de Pernambuco

Status: Enrolling

Conditions: Stroke

Treatments: Device: rTMSc; Behavioral: Neurofunctional physiotherapy; Device: rTMS sham

Study type: Interventional

Funder types: Other

Identifiers

NCT04816305

TMS_biomarkers_stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

rTMSc + physiotherapy

Experimental group

Description:

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.

Treatment:

Device: rTMSc

Behavioral: Neurofunctional physiotherapy

rTMSp + physiotherapy

Experimental group

Description:

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.

Treatment:

Device: rTMSc

Behavioral: Neurofunctional physiotherapy

tDCS sham + physiotherapy

Sham Comparator group

Description:

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.

Treatment:

Device: rTMS sham

Behavioral: Neurofunctional physiotherapy