NCT04245059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

January 22, 2020

Last Update Submit

November 3, 2020

Conditions

Healthy Subjects

Keywords

transcranial electrical stimulationtranscranial direct current stimulationmotor cortexmotor performancesecondary effects

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change of nine hole peg test score

    Baseline, 4 weeks

  • Change of grip strength measurement

    Baseline, 4 weeks

  • Change of pinch strength measurement

    Baseline, 4 weeks

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL

Each subject will receive transcranial electrical stimulation at primary motor cortex in both hemispheres. The pilot program will include 12 sessions with a frequency of 3 times per week during 4 weeks. Therefore, during tDCS sessions, subjects will receive stimulation for 20 minutes with a current of 2.0 milliamp using 6x4 cm electrodes. The participants will also complete a set of manual dexterity, grip and pinch tests bilaterally at baseline and post-intervention to determine if the subject responds to tDCS. Thus, each session will be monitored on safety aspects of the subjects with emphasis on skin disorders and other possible side effects of tDCS.

Device: Multi-channel Transcranial direct current stimulation

Interventions

Multi-channel Transcranial direct current stimulationDEVICE

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

Transcranial Direct Current Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (4)

  • 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.

    PMID: 22037126BACKGROUND

  • 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.

    PMID: 18957075BACKGROUND

  • 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.

    PMID: 30201910BACKGROUND

  • 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.

    PMID: 21819181BACKGROUND

Study Officials

  • Patricio E Barría Aburto, MSc.

    Corporación de Rehabilitacion Club de Leones Cruz del Sur

    PRINCIPAL INVESTIGATOR

  • Karim S Baleta Abarza, Lic.

    Corporación de Rehabilitacion Club de Leones Cruz del Sur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 28, 2020

Study Start

December 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)