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

U

University of Malaga

Status

Not yet enrolling

Conditions

Hemiparetic Cerebral Palsy

Treatments

Device: Anodic Transcranial Direct Current Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06438666
tDCS_2024UMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Children with spactic hemiparetic cerebral palsy
Experimental group
Description:
A group of children with spastic hemiparetic cerebral palsy will be treated with anodic transcranial direct currents.
Treatment:
Device: Anodic Transcranial Direct Current Stimulation

Trial contacts and locations

1

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Central trial contact

Rocío Martín Valero, PhD

Data sourced from clinicaltrials.gov

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