Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy (PeditCDS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiparetic Cerebral Palsy
• Intervention / Treatment: Device: Anodic Transcranial Direct Current Stimulation

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 Children's 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 (0,6 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rocío Martín Valero, PhD; Phone Number: 951952858; Email: rovalemas@uma.es

Study Locations

• Spain
  • Málaga, Spain, 29071
    • Rocío Martín Valero
    • Contact: Rocío Martín Valero, PhD; Phone Number: 951952858; Email: rovalemas@uma.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children between 14-18 years old.
• Children with spastic hemiparetic cerebral palsy diagnosis.
• Children with a cognitive level high enough to understand and to do the activities to value them.
• Children hemodynamically stable.
• Children forming part of levels II-IV of the Manual Ability Classification System (MACS).

Exclusion Criteria:

• Children with defibrillator.
• Children with pacemaker.
• Children with cerebral stimulator.
• Children with intracranial metallic implants.
• Children with opened cranial after clambering.
• Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results.
• Another circumstance where the electrotherapy treatment is contraindicated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children with spactic hemiparetic cerebral palsy; A group of children with spastic hemiparetic cerebral palsy will be treated with anodic transcranial direct currents.

Device: Anodic Transcranial Direct Current Stimulation; 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 sessions per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 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 sessions of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).	CHEQ is a questionnaire analyze the time it takes the children (between 6-18 years old) to do 29 functional activities; it also values the subjective experience of the children doing theses activities. It has a punctuation that goes from 1 to 4 (the maximum score is 348). If the score is higher, it means that the children's status is better.	Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes at the spasticity	Ashworth modified scale is a scale that values the spasticity. It has a punctuation that goes from 0 to 4. If the score is higher, it means that the spasticity is worse.	Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the active movement	Fugl-Meyer scale for upper limb Is a scale that values the active movement, the sensibility, joints pain and passive movement of the upper limb. It has a punctuation that goes from 0 to 2 (the maximun score is 126). If the score is higher, it means that all it values are fine.	Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the manual strength	Dynamometry is a test that values the hand strength.	Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the recruitment of the motor units.	Surface electromyography is a test that values the improvement in the recruitment of the motor units.	Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Jorge Manuel Góngora Rodríguez

Publications and helpful links

Helpful Links

• Mediline Plus
• Brain Stimulation Therapies

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Transcranial Direct Current Stimulation; Upper Limb
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: tDCS_2024UMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No