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TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931512
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Flix Díez, Centro Universitario La Salle

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 Intervention/treatment Phase
Healthy Device: transcranial direct current stimularion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 2, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 1, 2019

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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931512


Locations
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Spain
CEULaSalle
Madrid, Spain, 28023
Sponsors and Collaborators
Centro Universitario La Salle
Investigators
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Principal Investigator: Sergio L Lara, PhD University Studies Center La Salle
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Responsible Party: Laura Flix Díez, Physiotherapyst, Msc, Centro Universitario La Salle
ClinicalTrials.gov Identifier: NCT03931512    
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Flix Díez, Centro Universitario La Salle:
transcranial direct current stimulation
motor learning