tDCS Immediate Effect on Cardiorespiratory Parameters in Hemiparetics Adults Patients Due to Stroke.

NCT02398344 | Completed Phase 1 DMC

• 1 other identifier: '738.356
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies found important function of brain in exercises regulation on healthy and athlete patients and this studies showed not invasive stimulation on temporal cortex brain, induces electrics field to insula cortex, in addition modulate autonomic nervous system cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left temporal cortex in the cardiorespiratory parameters (functional capacity, perception of efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke. Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as: Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on right and left temporal cortex region (T3 area) and cathodic position in contralateral supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator turns on for 30 seconds. Results: The primary results will analyze cardiac frequency before and after tDCS and second step will assess the travelled distance on walking test for 6 minutes with and without tDCS and compare these respiratory reviews results with stroke gravity.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Cardiac Frequency Variability (HRV) as measured by spectral analysis by Polar RS800 cx.

  Individuals with right lesion, after anodal tDCS wolf T3 (healthy): BF (p=0,32), AF(p=0,88), LF/HF (p=0,18); tDCS in T4 (injured): BF (p=0,90), AF (p=0,19) and LF/HF (p=0,29). Individuals with left foot injury, tDCS in wolf T3 (injured) BF (p=0,15), AF (p=0,12) and LF/HF (p=0,81) and tDCS wolf T4 (healthy): BF (p=0,89), AF (p=0,18) and LF/HF (p=0,34).

  1 years

Study Arms (2)

1- tDCS ACTIVE

EXPERIMENTAL

1\. Transcranial stimulation ( tDCS ) will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes, intensity 2mA With Simulator anodic electro stimulation from bloodstream on right and left temporal cortex region (T3 area) and cathodic position in contralateral supraorbital region to anode (Fp2), associated Cardiac Frequency Variability (HRV) as measured by spectral analysis by spectral analysis Polar RS800 cx.

Device: tDCS active

2- tDCS SHAM

EXPERIMENTAL

Placebo tDCS will be administered using Tct Research 1 CH tdcs Simulator model 101 and will follow the same procedures as active tDCS active, but the tDCS device will only be switched on for 30 seconds.

Device: tDCS Sham

Interventions

tDCS active DEVICE

Transcranial direct current stimulation (tDCS) the active tDCS and placebo will be applied to the temporal cortex (T3) associated Cardiac Frequency Variability (HRV).

1- tDCS ACTIVE

tDCS Sham DEVICE

Active stimulation application time or placebo 20 minutes. In all sham stimulation, electrode placement procedures will also be performed like the procedures with anodic tDCS, the left and right temporal cortex, however, the stimulator is turned on for 30 seconds only, and the patient will be told that he will feel a slight initial tingling, but it will reduce, disappear or remain during the 20 minutes of application. Thus, individuals will feel it initially, but receive no stimulation in the remaining time. This procedure is a valid form of control in challenge studies transcranial direct current ³³. The equipment itself has a sham configuration.

2- tDCS SHAM

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals wich hemiparesis stemming from a stroke;
• Rating of Functional Mobility Scale levels (FMS- functional mobility scale)
• Walking at least 50 meters (GRAHAN et al. 2004); Science signature in consent term exempt and enlightened (TCLE) .

You may not qualify if:

• Positive Cutoff to cognitive wastage screening (mental mini) - Visual commitment may intervene in tests achievement;
• Cardiac vast problems and use of pacemaker;
• Contraindication of tDCS application (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site);

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Catarina NS Bertani, specialist

  University Nive July

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Catarina Novaes Sousa Bertani

Study Record Dates

• First Submitted: February 21, 2015
• First Posted: March 25, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

BR (1)