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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorUniversity of Malaga

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Children with defibrillator.

Children with pacemaker.

Children with cerebral stimulator.

Children with intracranial metallic implants.

Trial design

Design model

Single group

Treatments tested in this trial

  • Anodic Transcranial Direct Current Stimulation

    Device

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Children with spactic hemiparetic cerebral palsyExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Malaga

Lead sponsor

Jorge Manuel Góngora Rodríguez

Collaborator

This trial is not recruiting at the moment. You can still explore other options: