Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02956096
Status:
UNKNOWN
Last Update Posted:
2016-11-23
First Post:
2016-09-30
Brief Title:
Evaluation of Autonomic Modulation in Stroke After Transcranial Direct Current Stimulation and Treadmill Training
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25 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
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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None