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Non-invasive Stimulation on Central Nervous System Excitability

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ClinicalTrials.gov Identifier: NCT02659826
Recruitment Status : Unknown
Verified January 2016 by Kátia Monte-Silva, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

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).

Condition or disease Intervention/treatment Phase
Healthy Device: anodal tsDCS Device: cathodal tsDCS Device: sham tsDCS Device: Gait training Device: High frequency rTMS Device: Low frequency rTMS Device: sham rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Non-invasive Stimulation on Central Nervous System Excitability of Healthy Volunteers
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: anodal tsDCS and gait training
Volunteers will be submitted to anodal transcutaneous spinal cord stimulation and gait training
Device: anodal tsDCS
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.

Device: Gait training
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.

Experimental: cathodal tsDCS and gait training
Volunteers will be submitted to cathodal transcutaneous spinal cord stimulation and gait training
Device: cathodal tsDCS
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.

Device: Gait training
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.

Sham Comparator: sham tsDCS and gait training
Volunteers will be submitted to sham transcutaneous spinal cord stimulation and gait training
Device: sham tsDCS
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.

Device: Gait training
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.

Experimental: High frequency rTMS and gait training
Volunteers will be submitted to high frequency transcranial magnetic stimulation and gait training
Device: Gait training
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.

Device: High frequency rTMS
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.

Experimental: Low frequency rTMS and gait training
Volunteers will be submitted to low frequency transcranial magnetic stimulation and gait training
Device: Gait training
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.

Device: Low frequency rTMS
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.

Sham Comparator: sham rTMS and gait training
Volunteers will be submitted to sham transcranial magnetic stimulation and gait training
Device: Gait training
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.

Device: sham rTMS
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.




Primary Outcome Measures :
  1. Changes on spinal excitability [ Time Frame: six weeks (during stimulation protocol) ]
    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).


Secondary Outcome Measures :
  1. Changes on cortical brain activity (Intracortical inhibition) [ Time Frame: six weeks (during stimulation protocol) ]
    The short intracortical inhibition (SICI) will be evaluated through pp-TMS. Subthreshold conditioning stimuli (80% of rest motor threshold - RMT) and suprathreshold test stimuli (130% of RMT) will be delivered at 3 milliseconds of interstimulus intervals (ISI). Ten stimuli will be applied at each condition (unconditioned pulse and pairs of stimuli with ISI of 3 milliseconds). Stimuli order delivery will be pseudo-randomized and SICI will be expressed as conditioned stimulus percentage regarding an unconditioned stimulus.

  2. Changes on cortical brain activity (Intracortical facilitation) [ Time Frame: six weeks (during stimulation protocol) ]
    The intracortical facilitation (ICF) will be evaluated through pp-TMS. Subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (130% of RMT) will be delivered at 20 milliseconds of interstimulus intervals (ISI). Ten stimuli will be applied at each condition (unconditioned pulse and pairs of stimuli with ISI of 20 milliseconds). Stimuli order delivery will be pseudo-randomized and ICF will be expressed as conditioned stimulus percentage regarding an unconditioned stimulus.

  3. Changes on cortical brain activity motor evoked potential (MEP) [ Time Frame: six weeks (during stimulation protocol) ]
    The motor evoked potential (MEP) will be provided by ten unconditioned stimuli (130% RMT).


Other Outcome Measures:
  1. Perceived of effort level [ Time Frame: six weeks (during stimulation protocol) ]
    The Borg scale will be used to evaluate this measure. The volunteers will be enquired about their perceived of effort before, during (every three minutes) and after the gait training. Borg scale is an analogue scale graded from 6 (light exercise) to 20 points (exhaustive exercise).

  2. Heart rate [ Time Frame: six weeks (during stimulation protocol) ]
    To ensure that the exercise will be performed in a moderate intensity, the heart rate it will be monitored before, during (every three minutes ) and after the gait training by a cardiac polar.

  3. Subjective perception of pain [ Time Frame: six weeks (during stimulation protocol) ]
    the visual analog scale (VAS) will be apply to document the perception of pain. The VAS scores ranges from 0 (no perception of pain) to 10 (most pain I've felt).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02659826


Contacts
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Contact: Plínio K Albuquerque, MsC +5581998150256 plinioluna@gmail.com
Contact: Mayara FC Borba, PT +55 81 996921315 mayfcbl@gmail.com

Locations
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Brazil
Universidade Federal de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50670-901
Contact: Plínio L Albuquerque, MsC    +5581998150256    plinioluna@gmail.com   
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Study Director: Kátia K Monte-Silva, PhD Universidade Federal de Pernambuco
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Responsible Party: Kátia Monte-Silva, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02659826    
Other Study ID Numbers: NIS_CNSexcitability
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
Transcutaneous spinal direct current stimulation
Transcranial Magnetic Stimulation
Gait Training
Central Nervous System Excitability
Healthy