Hemiparetic Cerebral PalsyPeditCDSNCT06438666
Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy
A study testing Anodic Transcranial Direct Current Stimulation in people with Hemiparetic Cerebral Palsy, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Hemiparetic Cerebral Palsy
- What is being tested?
- Anodic Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2025to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Rocío Martín Valero
Málaga, 29071
Rocío Martín Valero, PhD, 951952858, rovalemas@uma.es
About this study
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
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.
Read the 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
- Being tested
- Anodic Transcranial Direct Current Stimulation
- Keywords
- Cerebral Palsy, Transcranial Direct Current Stimulation, Upper Limb
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodic Transcranial Direct Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with spactic hemiparetic cerebral palsy | Experimental | A group of children with spastic hemiparetic cerebral palsy will be treated with anodic transcranial direct currents. Receives: Device: Anodic Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start20 Oct 2025 (estimated)
- Primary completion23 Dec 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Jorge Manuel Góngora Rodríguez
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438666
- Sponsor's protocol ID
- tDCS_2024UMA
- Acronym
- PeditCDS
- Status last verified
- Jun 2025
- First submitted
- 23 May 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06438666
- Acronym / sponsor ID
- PeditCDS / tDCS_2024UMA
- Conditions
- Hemiparetic Cerebral Palsy
- Keywords
- Cerebral Palsy, Transcranial Direct Current Stimulation, Upper Limb
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Jorge Manuel Góngora Rodríguez
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Children with spactic hemiparetic cerebral palsy | Experimental | Device: Anodic Transcranial Direct Current StimulationA group of children with spastic hemiparetic cerebral palsy will be treated with anodic transcranial direct currents. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- Children with defibrillator.
- Children with pacemaker.
- Children with cerebral stimulator.
- Children with intracranial metallic implants.
- Children with opened cranial after clambering.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodic Transcranial Direct Current StimulationThis 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. | Device | Children with spactic hemiparetic cerebral palsy |
Primary outcome
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.
4 secondary outcomes
Changes at the spasticity
Time frame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the active movement
Time frame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the manual strength
Time frame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Changes at the recruitment of the motor units.
Time frame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Mediline PlusLink provided by the sponsor.
- Cerebral PalsyLink provided by the sponsor.
- Brain Stimulation TherapiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hemiparetic Cerebral Palsy
Active, not recruiting
Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy
Cerebral Palsy (CP), Hemiparetic Cerebral Palsy
Not yet recruiting
Mirror Therapy in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy, Mirror Hands
Not yet recruiting
Effect of Reciprocal Electrical Stimulation on Balance and Quality of Life in Hemiparetic CP
Hemiparetic Cerebral Palsy
Active, not recruiting
Effect of Blood Flow Restriction Training Exercises on Hand Grip Strength in Hemiparetic Cerebral Palsied Children
Cerebral Palsy Spastic Hemiplegic
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodic Transcranial Direct Current Stimulation in people with Hemiparetic Cerebral Palsy, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocío Martín Valero, PhD (951952858, rovalemas@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.