Clinical trial NCT04816305: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
Official title: Project NEUROMOD: Non-invasive Neuromodulation Guided Through Biomarkers in Patients With Stroke Sequels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Transcranial magnetic stimulation
Electroencephalogram
Physiotherapy
Brain symmetry
Biomarker
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain symmetry (baseline)
timeFrame: Before each session (10 sessions for 5 days a week for two weeks)
measure: Brain symmetry (post-treatment)
timeFrame: After each session (10 sessions for 5 days a week for two weeks)
measure: Brain symmetry (baseline)
timeFrame: Before each session (10 sessions for 5 days a week for two weeks)
measure: Brain symmetry (post-treatment)
timeFrame: After each session (10 sessions for 5 days a week for two weeks)
Secondary outcomes:
measure: Change in Fugl Meyer assesment of paretic upper limb motor function
timeFrame: 10 sessions (5 days a week for two weeks)
measure: Modified Ashworth Scale
timeFrame: 10 sessions (5 days a week for two weeks)
measure: The National Institutes of Health Stroke
timeFrame: 10 sessions (5 days a week for two weeks)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambucano
state: Pernambuco
Study officials:
References: