Clinical trial NCT04245059: Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study
Official title: Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Keywords: transcranial electrical stimulation
transcranial direct current stimulation
motor cortex
motor performance
secondary effects
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. It has been used to improve cognitive functions such as memory, language, and attention. Research has also shown that tDCS on motor cortex can improve motor performance.

TDCS secondary effects have been measured in several studies. The most frequent secondary effects described in literature are a mild tingling sensation, moderate fatigue, itching sensation, slight burning and mild pain sensation under the electrodes during the stimulation.

The present study is focused in evaluate the safety of a transcranial direct current stimulation (TDCS) service by measuring secondary effects incidence in a group of healthy subjects. In addition, manual dexterity and upper limb strength will be measure to identify improvement in motor performance after intervention.

Detailed description: Transcranial electrical stimulation (tES) is a neurophysiological technique capable of modulating the excitability of the neuronal tissue of the central and peripheral nervous system through the application, for a finite time length, of an electrical field. This electric field is generated by the application of weak electrical currents through the scalp and into the brain. It has been demonstrated in recent years that the technique is safe and beneficial if used within the known bounds of intensity, density and duration.

The tES technique is classified into three types according to the waveform of the stimulation current that is applied: Transcranial direct current stimulation (tDCS),Transcranial Alternating Current Stimulation (tACS) and Transcranial random noise stimulation (tRNS). Additionally, the Sham mode can be used for controlled experiments.

TDCS is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In general, the current is injected into the brain (anodal stimulation) over a cortical region leading to excitatory effects; and collected from the brain (cathodal stimulation) leading to inhibitory effects. tDCS produces short term effects on neuronal excitability, and long lasting plastic after/effects involving synaptic modification.

Research has shown that applying anodal tDCS to the non-dominant motor cortex can improve motor performance for the non-dominant hand, presumably by means of changes in synaptic plasticity between neurons. Other studies suggest improvement on cognitive functions such as memory, language, and attention after a tDCS program.

TDCS secondary effects have been measured in several studies. The most frequent secondary effects described in literature are a mild tingling sensation, moderate fatigue, itching sensation, slight burning and mild pain sensation under the electrodes during the stimulation. A visual sensation, associated with switching on and off the stimulation, have been also described. Less frequent are the difficulties in concentrating, headache, felt nervous or overexcited and nausea after the stimulation.

The present study is focused in evaluate the safety of a TDCS pilot program by measuring secondary effects incidence in a group of healthy subjects. In addition, manual dexterity and upper limb strength will be measure to identify improvement in motor performance after intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Both gender
* Informed consent accepted
* Adults

Exclusion Criteria:

* Neurological diseases
* Mental diseases
* Injuries in the scalp skin
* Inflammatory tegumentary diseases
* Migraines
* Medication or substances affecting central nervous system
* Presence of chronic diseases
* Presence of degenerative diseases
* Pregnancy

Primary outcomes:
measure: Change of block and box test score
timeFrame: Baseline, 4 weeks
measure: Change of Side effect checklist for transcranial direct current stimulation
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change of nine hole peg test score
timeFrame: Baseline, 4 weeks
measure: Change of grip strength measurement
timeFrame: Baseline, 4 weeks
measure: Change of pinch strength measurement
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Corporación de Rehabilitación Club de Leones Cruz del Sur
state: XII Región
Study officials:
affiliation: Corporación de Rehabilitacion Club de Leones Cruz del Sur
name: Patricio E Barría Aburto, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporación de Rehabilitacion Club de Leones Cruz del Sur
name: Karim S Baleta Abarza, Lic.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.
citation: Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103.
citation: Almousa A, Alajaji R, Alaboudi M, Al-Sultan F, Bashir S. Safety of Transcranial Direct Current Stimulation of Frontal, Parietal, and Cerebellar Regions in Fasting Healthy Adults. Behav Sci (Basel). 2018 Sep 10;8(9):81. doi: 10.3390/bs8090081.
citation: Paulus W. Transcranial electrical stimulation (tES - tDCS; tRNS, tACS) methods. Neuropsychol Rehabil. 2011 Oct;21(5):602-17. doi: 10.1080/09602011.2011.557292. Epub 2011 Aug 5.