TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

Transcranial Direct Current Stimulation Effects on Motor Learning and Motor Control in Healthy Subjetcs

Clinical Trial with two groups, transcranial direct current stimulation aplication and sham; triple blinded. The protocol is applied 5 consecutive days during the training of a manual dexterity task. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: transcranial direct current stimularion

Detailed Description

Clinical Trial with two groups, transcranial direct current stimulation aplication (1 mA ) and sham (ramp up and down of 30 seconds in total) . Bouth interventions will last 20 minutes; at the same time of the aplication bouth are going to train the manual dexterity with Purdue Pegboard Test.

This protocol is applied 5 consecutive days, also it have a follow up of 5 days more.

It is triple blinded. Manual dexterity and somatosensory variables are measured pre intervention, post one day of intervention, post 5 days of intervention, and 5 days after finish the intervention.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • CEULaSalle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• metal or skin lesions on the head
• brain stimulation in the last 6 months
• family history of epilepsy or seizures
• pacemaker or any cardiac involvement
• inability to understand or execute the task
• taking drugs that may influence cognition
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transcranial direct current stimulation; 20 minutes of transcranial direct current stimulation 1 mA on bi-hemispheric colocation with cathode on the left M1 and anode on the right M1	Device: transcranial direct current stimularion; aplication of direct current stimulation on the scalp wiht sponge electrodes
Sham Comparator: sham transcrial direct current stimulation; 20 minutes positioning the electrodes on the scalp. Whith an initial increasing of the current intensity by 10 seconds, until 1mA and a ramp down from 20 seconds to reach zero.	Device: transcranial direct current stimularion; aplication of direct current stimulation on the scalp wiht sponge electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in trained manual dexterity of the dominant hand	One hand manual dexterity is measured with Perdue Pegboard test	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in trained manual dexterity of bouth hands	Two hands dexterity is measured with Perdue Pegboard test	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in maximal isometric hand grip force	Hand grip force is measured with Jamar dinamometer	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Sleep Quality	Pittsburgh Sleep Quality Index	5 days after finish the intervention
Physical activity	Long form of the International Physical Activity Questionnaire	5 days after finish the intervention
Changes in nontrained manual dexterity of the dominant hand	One hand dexterity is mesured with Minesota Test	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in nontrained manual dexterity of bouth hands	Two hands dexterity is mesured with Minesota Test	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pressure detection treshold	The pressure detection treshold is measured with an algometer	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in pain detection treshold	The pain detection treshold is measured with an algometer	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention
Changes in two points discrimination	Two points discrimination is measured with an esthesiometer	pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention

Collaborators and Investigators

• Sponsor: Centro Universitario La Salle
• Investigators: Principal Investigator: Sergio Lerma Lara, PhD, University Studies Center La Salle

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; motor learning
• Other Study ID Numbers: R-0022/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual praticipant data is going to be anonymized. Also, the participants are going to sing the consent of shareing his personal data.
• IPD Sharing Time Frame: Just before the clinical trial will be ended, and in an unlimited frame of time.
• IPD Sharing Access Criteria: With resaserches that will need this information for another studies.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No