NCT02956096

Evaluation of Autonomic Modulation in Stroke After Transcranial Direct Current Stimulation and Treadmill Training

Evaluation of Autonomic Modulation in the Hemiparetic Patients After Transcranial Direct Current Stimulation (tDCS) and Treadmill Training: Clinical Trial, Controlled, a Randomized, Double-blind

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 21 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS)	The active tDCS and placebo will be applied to anode electrode on left temporal cortex placed on the scalp in the region T3. The cathode electrode on the middle deltoid muscle contralateral to the anode.
DEVICE	training on the running belt	The running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-05-01
• Completion: 2017-11-01
• First posted: 2016-11-04
• Last updated: 2016-11-23

Locations

1 site across 1 country: Brazil