Viewing Study NCT06438666



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06438666
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-03
First Post: 2024-05-23

Brief Title: Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation tCDS in Children With Spastic Hemiparetic Cerebral Palsy
Sponsor: University of Malaga
Organization: University of Malaga

Study Overview

Official Title: A Quasi Experimental Study About the Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation in Children With Spastic Hemiparetic Cerebral Palsy
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PeditCDS
Brief Summary: Spastic Hemiparetic Cerebral Palsy SHCP uses to limit the manual function Using anodic transcranial direct current stimulation it is possible to activate certain cerebral areas depending on where the electrodes are This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects
Detailed Description: It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement It will value the time that the children spend doing the bimanual activities described by the Childrens Hand-Use Experience Questionnaire CHEQ it will also value the subjective experience doing those activities it will analyze the active movement Fugl-Meyer for upper limb spasticity modified Ashworth manual strength dynamometry and the recruitment improvement surface electromyography too

This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old The protocol that it will follow is the next one 3 days to value the outcome measures 4 days 1 session per day of 17 minutes and 30 seconds to apply the protocol of anodic transcranial direct current stimulation 06 mA of intensity It will use the EPTE V07 Bipolar System by IONCLINICS 3 days to value the outcome measures studying the effects produced at the affected upper limb Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None