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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06438666
Acronym
PeditCDS
Enrollment
20
Registered
2024-06-03
Start date
2025-10-20
Completion date
2027-03-20
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparetic Cerebral Palsy

Keywords

Cerebral Palsy, Transcranial Direct Current Stimulation, Upper Limb

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.

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.

Sponsors

Jorge Manuel Góngora Rodríguez
CollaboratorUNKNOWN
University of Malaga
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).Baseline, after 4 days (after de foruth sessions planned) and 3 weeks laterCHEQ 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

MeasureTime frameDescription
Changes at the spasticityBaseline, after 4 days (after the fourth sessions planned) and 3 weeks laterAshworth 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.
Changes at the active movementBaseline, after 4 days (after the fourth sessions planned) and 3 weeks laterFugl-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.
Changes at the manual strengthBaseline, after 4 days (after the fourth sessions planned) and 3 weeks laterDynamometry is a test that values the hand strength.
Changes at the recruitment of the motor units.Baseline, after 4 days (after the fourth sessions planned) and 3 weeks laterSurface electromyography is a test that values the improvement in the recruitment of the motor units.

Countries

Spain

Contacts

Primary ContactRocío Martín Valero, PhD
rovalemas@uma.es951952858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026