Non-invasive Stimulation on Central Nervous System Excitability

NCT02659826 | Unknown DMC

• 1 other identifier: NIS_CNSexcitability
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A crossover trial with healthy volunteers will be conducted. Six sessions will be performed once a week in a counterbalanced order and at least with seven days washout period to minimize carry-over effects. In each session, volunteers will be submitted to quantity and quality of sleep, type of eating, fatigue and motivation level, cortical brain activity measures through paired pulse transcranial magnetic stimulation (ppTMS), spinal cord activity measures through electrical stimulation, non-invasive spinal stimulation (tsDCS) or non-invasive brain stimulation (rTMS) and physical exercise (gait training).

Conditions

Healthy

Keywords

Transcutaneous spinal direct current stimulation; Transcranial Magnetic Stimulation; Gait Training; Central Nervous System Excitability; Healthy

Outcome Measures

Primary Outcomes (1)

• Changes on spinal excitability

  Spinal excitability measures will be assessed by electrical stimulation of the tibial nerve (H-reflex and homosynaptic depression) and sural nerve (withdrawal reflex). The volunteer should stay in prone position for the stimulation of the tibial nerve (in the region of the popliteal fossa) and then in the lateral position for the stimulation of the sural nerve (in retromalleolar region).

  six weeks (during stimulation protocol)

Secondary Outcomes (3)

• Changes on cortical brain activity (Intracortical inhibition)

  six weeks (during stimulation protocol)

• Changes on cortical brain activity (Intracortical facilitation)

  six weeks (during stimulation protocol)

• Changes on cortical brain activity motor evoked potential (MEP)

  six weeks (during stimulation protocol)

Other Outcomes (3)

• Perceived of effort level

  six weeks (during stimulation protocol)

• Heart rate

  six weeks (during stimulation protocol)

• Subjective perception of pain

  six weeks (during stimulation protocol)

Study Arms (6)

anodal tsDCS and gait training

EXPERIMENTAL

Volunteers will be submitted to anodal transcutaneous spinal cord stimulation and gait training

Device: anodal tsDCS; Device: Gait training

cathodal tsDCS and gait training

EXPERIMENTAL

Volunteers will be submitted to cathodal transcutaneous spinal cord stimulation and gait training

Device: cathodal tsDCS; Device: Gait training

sham tsDCS and gait training

SHAM COMPARATOR

Volunteers will be submitted to sham transcutaneous spinal cord stimulation and gait training

Device: sham tsDCS; Device: Gait training

High frequency rTMS and gait training

EXPERIMENTAL

Volunteers will be submitted to high frequency transcranial magnetic stimulation and gait training

Device: Gait training; Device: High frequency rTMS

Low frequency rTMS and gait training

EXPERIMENTAL

Volunteers will be submitted to low frequency transcranial magnetic stimulation and gait training

Device: Gait training; Device: Low frequency rTMS

sham rTMS and gait training

SHAM COMPARATOR

Volunteers will be submitted to sham transcranial magnetic stimulation and gait training

Device: Gait training; Device: sham rTMS

Interventions

anodal tsDCS DEVICE

Transcutaneous spinal cord stimulation will be delivered through a direct current (DC) stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The active electrode (anode) will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 milliampere (mA), fade in and fade out of 10 seconds, during 20 minutes.

anodal tsDCS and gait training

cathodal tsDCS DEVICE

Transcutaneous spinal cord stimulation will be delivered through a DC stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The active electrode (cathode) will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 mA, fade in and fade out of 10 seconds, during 20 minutes.

cathodal tsDCS and gait training

sham tsDCS DEVICE

sham transcutaneous spinal cord stimulation will be delivered through a DC stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The electrode anode will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 mA, fade in and fade out of 10 seconds, during only 30 seconds but the volunteers will continue with electrodes montage for 20 minutes.Thus, early sensations (eg. mild to moderate tingling or itch) on stimulation site will be experienced without inducing any modulatory effects.

sham tsDCS and gait training

Gait training DEVICE

It consists of moderate gait training exercise for 20 minutes. To ensure that the exercise will be performed at moderate intensity will be used the 64% - 76% of maximum heart rate (HRmax = 220-age). Heart rate will be monitored every three minutes through a heart polar. In addition will be monitored perceived effort, gait speed and inclination of the treadmill. The Borg scale will be used to evaluate perceived effort. This is an analogue scale graded from 6 (light exercise) to 20 points (exhaustive exercise). Information about the exercise on the treadmill will be noted in the evolution record.

High frequency rTMS and gait training; Low frequency rTMS and gait training; anodal tsDCS and gait training; cathodal tsDCS and gait training; sham rTMS and gait training; sham tsDCS and gait training

High frequency rTMS DEVICE

Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and positioned over the scalp (C3 - 10/20 System) at an angle of 45 degrees from the midline pointed to the target muscle (FDI). Thereafter, RMT will be measure. rTMS protocols was based on previous studies. High frequency protocol: 20 hertz (Hz), 90% RMT, 45 trains, 40 stimuli per train, inter interval of 28 seconds, 1800 stimuli. After each rTMS session, presence of adverse effects will be computed.

High frequency rTMS and gait training

Low frequency rTMS DEVICE

Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and positioned over the scalp (C3 - 10/20 System) at an angle of 45 degrees from the midline pointed to the target muscle (FDI). Thereafter, RMT will be measure. Low frequency protocol: 1Hz, 90% RMT, 1500 stimuli (1 train). After each rTMS session, presence of adverse effects will be computed.

Low frequency rTMS and gait training

sham rTMS DEVICE

The hotspot of first right dorsal interosseous (FDI) muscle will be determinate through a figure-eight coil connected to the magnetic stimulator positioned over the motor primary cortex (C3). Then, the motor threshold (RMT) of FDI will be measure. Sham rTMS will be performed with low frequency (1Hz, 90% RMT, 1500 stimuli) protocol using two coils. The first one - connected to the stimulator - will be positioned on a coil support close to the volunteer but not visible. Therefore, characteristic stimulation noises will be audible. The second - disconnected to the stimulator - will be placed over left primary motor area. After each rTMS session, presence of adverse effects will be computed.

sham rTMS and gait training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed (assessed by Edinburgh Handedness Inventory)
• Healthy volunteers (self report)
• Sedentary or irregularly active (short version of the International Physical Activity Questionnaire)
• Contraceptive medication for women
• Without using drugs or neuroactive substances regularly

You may not qualify if:

• Pregnancy
• Presence of metallic implant close to the target stimulation area
• Acute eczema under the target stimulation area
• Pacemaker
• History of seizures or epilepsy
• Hemodynamic instability

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Study Officials

• Kátia K Monte-Silva, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

Plínio K Albuquerque, MsC

CONTACT

+5581998150256; plinioluna@gmail.com

Mayara FC Borba, PT

CONTACT

+55 81 996921315; mayfcbl@gmail.com

Study Design

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

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: January 20, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

BR (1)