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

NCT06438666 | Not Yet Recruiting

• 1 other identifier: tDCS_2024UMA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparetic Cerebral Palsy

Keywords

Cerebral Palsy; Transcranial Direct Current Stimulation; Upper Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes at the spasticity

  Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later

• Changes at the active movement

  Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later

• Changes at the manual strength

  Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later

• Changes at the recruitment of the motor units.

  Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later

Study Arms (1)

Children with spactic hemiparetic cerebral palsy

EXPERIMENTAL

A group of children with spastic hemiparetic cerebral palsy will be treated with anodic transcranial direct currents.

Device: Anodic Transcranial Direct Current Stimulation

Interventions

Anodic Transcranial Direct Current Stimulation DEVICE

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.

Children with spactic hemiparetic cerebral palsy

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead
• Jorge Manuel Góngora Rodríguez: collaborator

Study Sites (1)

Rocío Martín Valero

Málaga, 29071, Spain

Location

Related Links

• Mediline Plus
• Brain Stimulation Therapies

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Rocío Martín Valero, PhD

CONTACT

951952858; rovalemas@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 20 participants between 14-18 years old will receive 4 sessions of anodic transcranial direct current stimulation. The results will be measured before and after the 4 sessions.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)