Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study

Healthy Subjects Clinical Trial

Official title:

Safety Study Based on Transcranial Electrical Stimulation in Chile: a Case Series Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04245059
• Other study ID #: CorporacionRCLCS0002
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: Corporación de Rehabilitación Club de Leones Cruz del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Multi-channel Transcranial direct current stimulation
A commercial tDCS device will be use in this study. The device is a wireless multi-channel transcranial direct current stimulator that incorporates an 8-channel headcap for stimulation through gel electrodes or classic sponge electrodes. The device is integrated with a user interface for the configuration and monitoring of the stimulus parameters and a fast multifocal simulation of the tDCS electric field using an advanced brain model

Locations

Country	Name	City	State
Chile	Corporación de Rehabilitación Club de Leones Cruz del Sur	Punta Arenas	XII Región

Sponsors (1)

Lead Sponsor	Collaborator
Corporación de Rehabilitación Club de Leones Cruz del Sur

Country where clinical trial is conducted

Chile, 

References & Publications (4)

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). pii: E81. doi: 10.3390/bs8090081. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of block and box test score	Change of the Box and Block test score, it's a measure of the number of blocks the subject can move in 1 minute, between the beginning (T0) and immediately after the end of treatment (T1). Range of score 0-120. A positive change represents improved performance on Box and Blocks test.	Baseline, 4 weeks
Primary	Change of Side effect checklist for transcranial direct current stimulation	A checklist that records side effect after TDCS sessions including fatigue, headache or dizziness, nausea, and a itching sensation in the stimulation area.	Baseline, 4 weeks
Secondary	Change of nine hole peg test score	The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs.	Baseline, 4 weeks
Secondary	Change of grip strength measurement	Change of value of kilogram - force (kgf) measured with a handheld dynamometer on a single grip test of maximum contraction for 3 seconds.	Baseline, 4 weeks
Secondary	Change of pinch strength measurement	Change of value of kilogram - force (kgf) measured with a handheld dynamometer on a single pinch test of maximum contraction for 3 seconds.	Baseline, 4 weeks