TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

NCT03931512 | Completed

• 1 other identifier: R-0022/18
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

transcranial direct current stimulation; motor learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Changes in trained manual dexterity of bouth hands

  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

  pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention

• Sleep Quality

  5 days after finish the intervention

• Physical activity

  5 days after finish the intervention

• Changes in nontrained manual dexterity of the dominant hand

  pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention

Study Arms (2)

transcranial direct current stimulation

EXPERIMENTAL

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

sham transcrial direct current stimulation

SHAM COMPARATOR

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

Interventions

transcranial direct current stimularion DEVICE

aplication of direct current stimulation on the scalp wiht sponge electrodes

sham transcrial direct current stimulation; transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CEULaSalle

Madrid, 28023, Spain

Location

Study Officials

• Sergio Lerma Lara, PhD

  University Studies Center La Salle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapyst, Msc

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 30, 2019
• Study Start: April 30, 2019
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Just before the clinical trial will be ended, and in an unlimited frame of time.
• Access Criteria: With resaserches that will need this information for another studies.

Locations

ES (1)