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

NCT02956096 | Unknown DMC

• 1 other identifier: u64963ep
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

tDCS; Stroke; Autonomic Modulation

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Cardiac Frequency Variability (HRV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in ms²

  1 years

Secondary Outcomes (1)

• Blood pressure variability

  1 years

Study Arms (2)

tDCS device and Treatmill

ACTIVE COMPARATOR

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); Device: training on the running belt

1- tDCS

SHAM COMPARATOR

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); Device: training on the running belt

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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.

1- tDCS; tDCS device and Treatmill

training on the running belt DEVICE

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.

1- tDCS; tDCS device and Treatmill

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University Nove de Julho

São Paulo, São Paulo, 01504001, Brazil

Location

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Related Links

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MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Glauber Heinz, Postgraduate

CONTACT

5511970883072; glauber.heinz@hotmail.com

Glauber Heinz, Postgraduate

CONTACT

551150541825; glauber.heinz@uninove.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: November 4, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 23, 2016

Record last verified: 2016-09

Locations

BR (1)