Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anodic Transcranial Direct Current Stimulation.
- Who it may be relevant to
- Registry conditions: Hemiparetic Cerebral Palsy. Basic parameters: 14 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device 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
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Rocío Martín Valero — Málaga
Identifiers
NCT: NCT06438666 · tDCS_2024UMA