Clinical trial NCT06438666: Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation (tCDS) in Children With Spastic Hemiparetic Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiparetic Cerebral Palsy
Keywords: Cerebral Palsy
Transcranial Direct Current Stimulation
Upper Limb
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Jorge Manuel Góngora Rodríguez
First posted: 2024-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).
timeFrame: Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later
Secondary outcomes:
measure: Changes at the spasticity
timeFrame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
measure: Changes at the active movement
timeFrame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
measure: Changes at the manual strength
timeFrame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
measure: Changes at the recruitment of the motor units.
timeFrame: Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Rocío Martín Valero
Study officials:
References: