Status:
NOT_YET_RECRUITING
Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage
Lead Sponsor:
Universidad Francisco de Vitoria
Collaborating Sponsors:
Universidad Nacional de Educación a Distancia
Hospital Beata María Ana
Conditions:
Paediatric Brain Damage
Cerebral Palsy
Eligibility:
All Genders
7-15 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to acknowledge the effects of transcranial direct current stimulation as an adjuvant with gaming rehabilitation for upper limb function rehabilitation in paediatric ...
Detailed Description
Paediatric brain damage is categorized into two main types: cerebral palsy, characterized by permanent impairments in posture and movement due to non-progressive brain injuries during gestation and ea...
Eligibility Criteria
Inclusion
- Ischemic or hemorrhagic stroke.
- Traumatic brain injury.
- Cerebral palsy.
- Acquired Brain Injury.
- Other causes of non-progressive brain damage susceptible to treatment with the established procedures.
- Evolution of the injury of at least one year.
- Age between 7 and 15 years, with adequate language development and capacity to comprehend the proposed procedure.
- Neuroimaging study done.
- Absence of previous brain injuries prior to the one prompting treatment.
- Score between II and IV on the MACS scale for manual ability assessment.
- Signed informed consent by the patient and their legal guardian in case the participant is 12 or older. If the participant is younger than 12 years, only the caregiver signed informed consent will be necessary.
- Increased tone according to the modified Ashworth scale ranging from 1 to 1+.
- Minimum score of 1 on each item assessed in the Melbourne Assessment 2 scale.
Exclusion
- Dermatological problems in the electrode application area (psoriasis, dermatitis on the scalp or face).
- Presence of implants or metal pieces in the head excluding fillings.
- Pacemakers, medication pumps, stimulators (vagal, cerebral, transcutaneous), ventriculoperitoneal shunts, or aneurysm clips.
- Neurological disease different from that described in the inclusion criteria.
- Significant language difficulties that unable proper understanding of activities or severely limit expression.
- Moderate or severe mood disorders diagnosed by the regular pediatrician.
- Uncontrolled medical issues (acute phase pathologies without medical or pharmacological treatment with proven efficacy or life-threatening conditions).
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06214364
Start Date
June 1 2024
End Date
January 1 2026
Last Update
May 9 2024
Active Locations (1)
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1
Beata Maria Ana Hospital
Madrid, Spain, 28007