ClinicalTrials.gg
Not yet recruitingNCT06438666PeditCDSUpdated Jun 18, 2025

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

An interventional study of Anodic Transcranial Direct Current Stimulation in Hemiparetic Cerebral Palsy, sponsored by University of Malaga. Not yet recruiting at 1 site in Spain. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by University of Malaga · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 54 studies in Cerebral Palsy with a site in Spain — 15 open to participants now, 18 under way, 1 of them phase 3. Cerebral Palsy · Spain.

Planned enrollment
32nd of 44
20 · median 32
Started
2025
with 6 others
No phase
37 of 54
12 open now
Primary completion
2026-12
later than 14 of 17 live
Registered
40th of 54
by date

Among the 54 studies in Cerebral Palsy with a site in Spain, this one is the 32nd largest by planned enrollment of the 44 interventional ones that give a count, is one of 7 that started in 2025, is one of 37 with no phase, reaches primary completion later than 14 of the 17 other live ones, and was the 40th registered.

Cerebral Palsy

1,937 studies on the registry are indexed under Cerebral Palsy; 457 are open to participants now.

Browse Cerebral Palsy studies →

Open to participants now

15 of the 54 studies in Cerebral Palsy with a site in Spain are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 269 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 234 (87%) stop at 75 or younger; 254 take children under 18; 51 take healthy volunteers.

This study: 14 Years to 18 Years · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Hemiparetic Cerebral Palsy

Browse trials for

Keywords

  • Cerebral Palsy
  • Transcranial Direct Current Stimulation
  • Upper Limb
04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceAnodic 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. Changes at the manual strength

    Dynamometry is a test that values the hand strength.

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

  4. Changes at the recruitment of the motor units.

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

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2025; primary completion for Dec 2026, 14 months later.

Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 14 months is above that.

Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
Jun 3, 2024
StartEst.
Oct 20, 2025
Primary completionEst.
Dec 23, 2026
CompletionEst.
Mar 20, 2027
Last update
Jun 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06438666
Collaborators
Jorge Manuel Góngora Rodríguez
Responsible party
Rocío Martín Valero (Director, University of Malaga) — Principal investigator
First posted
Jun 3, 2024
Start date
Oct 20, 2025 (estimated)
Primary completion
Dec 23, 2026 (estimated)
Completion
Mar 20, 2027 (estimated)
Last update
Jun 18, 2025

Study contacts

Rocío Martín Valero, PhD
Contact
rovalemas@uma.es
951952858

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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