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

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ClinicalTrials.gov Identifier: NCT02956096
Recruitment Status : Unknown
Verified September 2016 by Glauber Heinz, University of Nove de Julho.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Glauber Heinz, University of Nove de Julho

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Transcranial direct current stimulation (tDCS) Device: training on the running belt Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Active Comparator: tDCS device and Treatmill
The stimulation is accomplished with a direct current-tDCS Stimulator Plus device, via two surface electrodes sponge (non-metallic) 5-7 cm2 in saline moistened with a 2mA current during 20 minutes after hemodinamic analysis is performed for 15 minutes and then made only training treadmill for 20 minutes. Placebo tDCS will follow the same procedures, but the tDCS device will only be switched on for 20 seconds. 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 (MACKO , 2005).
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.

Sham Comparator: 1- tDCS
1. Who received stimulation transcranial direct current active will receive Sham stimulation and who received the placebo stimulation receive active stimulation and then the two groups will do the workout on the treadmill
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.




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 1 years ]
    Cardiac Frequency Variability (HRV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in ms²


Secondary Outcome Measures :
  1. Blood pressure variability [ Time Frame: 1 years ]
    Blood Pressure Variability (BPV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in mmHg



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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956096


Contacts
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Contact: Glauber Heinz, Postgraduate 5511970883072 glauber.heinz@hotmail.com
Contact: Glauber Heinz, Postgraduate 551150541825 glauber.heinz@uninove.edu.br

Locations
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Brazil
University Nove de Julho Not yet recruiting
São Paulo, SP, Brazil, 01504001
Contact: Glauber Heinz, Postgraduate    5511970883072    glauber.heinz@hotmail.com   
Sponsors and Collaborators
University of Nove de Julho

Additional Information:
Publications:
Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum in: Stroke. 2019 Aug;50(8):e239.

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Responsible Party: Glauber Heinz, Physiotherapist, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02956096     History of Changes
Other Study ID Numbers: u64963ep
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Glauber Heinz, University of Nove de Julho:
tDCS
Stroke
Autonomic Modulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases