Clinical trial NCT02956096: Evaluation of Autonomic Modulation in Stroke After Transcranial Direct Current Stimulation and Treadmill Training
Official title: Evaluation of Autonomic Modulation in the Hemiparetic Patients After Transcranial Direct Current Stimulation (tDCS) and Treadmill Training: Clinical Trial, Controlled, a Randomized, Double-blind
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: tDCS
Stroke
Autonomic Modulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.

Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.

Detailed description: Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.

Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.

Methods: Clinical study, crossover, controlled, randomized, double-blind individuals with hemiparesis after stroke adults. Patients will undergo a spirometric evaluation (Harbor protocol modified with constant speed, determined by the individual and the incline of the treadmill with incremented 2.5% every 2 minutes). The next day will begin with one of the two randomized protocols, one week interval between them: 1 (tDCS active and treadmill), 2 (tDCS placebo and treadmill). Each protocol will last 40 minutes (20min of tDCS over 20min mat). They will be evaluated heart rate variability (HRV) and blood pressure variability (VPA) before a minute for the protocols and in the recovery phase, for 15 minutes. 2mA current intensity, the anode electrode over the left temporal cortex and cathode on the contralateral deltoid muscle. Considering the neurophysiological effects of noninvasive techniques neuromodulators plasticity before the modulation of the autonomic nervous system, it is concluded that this study shows potential for the discovery of a new therapeutic tool in the rehabilitation of patients with stroke and hypertension. The hypothesis is that increasing the excitability of the left insular cortex, a modulation of the autonomic nervous system in controlling the variability in systolic blood pressure and heart rate is possible in conjunction with aerobic training, can provide greater hemodynamic effectiveness and decrease the time training. It is also understood that the study may have impact on the reduction of public costs spent on the rehabilitation of patients with stroke.

Eligibility criteria: Inclusion Criteria:

* present hemiparesis due to stroke for more than 6 months;
* Commitment mild or moderate motor in the lower member (20 to 31 points), according to the scores of Fugl-Meyer test
* comfortable walking speed on the ground between 0.3 and 1.15 m / s;
* Rating between levels 04-06 on Functional Mobility Scale (FMS) - Functional Mobility Scale and ambulate at least 50 meters
* Presentation of the AVE imaging
* Science Signature regarding the free and informed consent (WIC).

Exclusion Criteria:

* present cognitive impairment (mini mental) with scores below 24 points;
* visual impairment that may interfere with the performance of the tests;
* severe heart failure (congestive heart failure, angina, peripheral vascular disease), pacemaker use, β-blockers and propranolol;
* contraindications to the use of tDCS (brain implants of metal clips near the region to be stimulated, history of recurrent seizures, recurrent epilepsy and brain tumors, brain pacemaker and / or plates or metal devices in place of stimulation tDCS)
* irregular menstrual cycle or be in the menstrual period during the evaluation;
* No medical certificate for treadmill exercise test

Primary outcomes:
measure: Heart rate variability
timeFrame: 1 years
Secondary outcomes:
measure: Blood pressure variability
timeFrame: 1 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
state: SP
Study officials:
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