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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

Clinicaltrials.gov identifier NCT03931512

Recruitment Status Completed

First Posted April 30, 2019

Last update posted October 7, 2019

Study Description

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.

  • Condition or Disease:Healthy
  • Intervention/Treatment: Device: transcranial direct current stimularion
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 33 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Transcranial Direct Current Stimulation Effects on Motor Learning and Motor Control in Healthy Subjetcs
  • Actual Study Start Date: March 2018
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: June 2019
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Change in trained manual dexterity of the dominant hand [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    One hand manual dexterity is measured with Perdue Pegboard test
  • Secondary Outcome Measures: 1. Changes in trained manual dexterity of bouth hands [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    Two hands dexterity is measured with Perdue Pegboard test
  • 2. Changes in maximal isometric hand grip force [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    Hand grip force is measured with Jamar dinamometer
  • 3. Sleep Quality [ Time Frame: 5 days after finish the intervention ]
    Pittsburgh Sleep Quality Index
  • 4. Physical activity [ Time Frame: 5 days after finish the intervention ]
    Long form of the International Physical Activity Questionnaire
  • 5. Changes in nontrained manual dexterity of the dominant hand [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    One hand dexterity is mesured with Minesota Test
  • 6. Changes in nontrained manual dexterity of bouth hands [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    Two hands dexterity is mesured with Minesota Test
  • 7. Changes in pressure detection treshold [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    The pressure detection treshold is measured with an algometer
  • 8. Changes in pain detection treshold [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    The pain detection treshold is measured with an algometer
  • 9. Changes in two points discrimination [ Time Frame: pre intervention, post one day of intervention, post 5 days of intervention, 5 days after finish the intervention ]
    Two points discrimination is measured with an esthesiometer
Eligibility Criteria
  • Ages Eligible for Study: 18 to 35 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

Spain
CEULaSalle
Madrid

Sponsors and Collaborators

Centro Universitario La Salle

Investigators

Principal Investigator: Sergio L Lara, PhD University Studies Center La Salle

More Information
  • Responsible Party: Centro Universitario La Salle
  • ClinicalTrials.gov Identifier: NCT03931512 History of Changes
  • Other Study ID Numbers: R-0022/18
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: October 7, 2019
  • Last Verified: October 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • 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.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centro Universitario La Salle: transcranial direct current stimulation motor learning