Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04245059
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2020-01-22
Brief Title:
Safety Study Based on Transcranial Electrical Stimulation in Chile a Case Series Study
Sponsor:
Corporación de Rehabilitación Club de Leones Cruz del Sur
Organization:
Corporación de Rehabilitación Club de Leones Cruz del Sur
Study Overview
Official Title:
Safety Study Based on Transcranial Electrical Stimulation in Chile a Case Series Study
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 tDCSTranscranial 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 aftereffects 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
The tES technique is classified into three types according to the waveform of the stimulation current that is applied Transcranial direct current stimulation tDCSTranscranial 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 aftereffects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None