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

NCT ID: NCT06438666

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2027-03-20

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 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.

Conditions

Hemiparetic Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Children with spactic hemiparetic cerebral palsy

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

Group Type: EXPERIMENTAL

Anodic Transcranial Direct Current Stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jorge Manuel Góngora Rodríguez

UNKNOWN

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Rocío Martín Valero

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rocío Martín Valero

Málaga, , Spain

Countries

Spain

Central Contacts

Rocío Martín Valero, PhD

Role: CONTACT

rovalemas@uma.es

951952858

Facility Contacts

Rocío Martín Valero, PhD

Role: primary

rovalemas@uma.es

951952858

Related Links

https://medlineplus.gov/spanish/

Mediline Plus

https://www.nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies

Brain Stimulation Therapies

Other Identifiers

tDCS_2024UMA

Identifier Type: -

Identifier Source: org_study_id