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NCT Number: NCT06438666

Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) 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.

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Key information

Conditions

Hemiparetic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).

    Time frame: Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later

    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.

Secondary outcomes

  1. Changes at the spasticity

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

    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.

  2. Changes at the active movement

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

    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.

  3. Changes at the manual strength

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

    Dynamometry is a test that values the hand strength.

  4. Changes at the recruitment of the motor units.

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

    Surface electromyography is a test that values the improvement in the recruitment of the motor units.

Study contacts

Contact information is provided by the study sponsor or research team.

Rocío Martín Valero, PhD

CONTACT

[email protected]

951952858

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • Jorge Manuel Góngora Rodríguez

Registry information

Official study 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

Acronym: PeditCDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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