TDCS Effects on Motor Learning and Motor Control in Healthy Subjetcs

• Sponsor: Centro Universitario La Salle (Other)
• Overall Status: Completed
• CT.gov ID: NCT03931512
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 31.4

Study Details

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	Intervention/Treatment	Phase
Healthy	Device: transcranial direct current stimularion	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: Apr 30, 2019
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in trained manual dexterity of the dominant hand [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 [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 [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 [5 days after finish the intervention]

   Pittsburgh Sleep Quality Index

4. Physical activity [5 days after finish the intervention]

   Long form of the International Physical Activity Questionnaire

5. 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]

   One hand dexterity is mesured with Minesota Test

6. Changes in nontrained manual dexterity of bouth hands [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CEULaSalle	Madrid		Spain	28023

Sponsors and Collaborators

• Centro Universitario La Salle

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Flix Díez, Physiotherapyst, Msc, Centro Universitario La Salle
• ClinicalTrials.gov Identifier: NCT03931512
• Other Study ID Numbers: R-0022/18
• First Posted: Apr 30, 2019
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laura Flix Díez, Physiotherapyst, Msc, Centro Universitario La Salle: transcranial direct current stimulation; motor learning

Study Results

No Results Posted as of Jun 23, 2022