Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pe… (NCT06214364) | Clinical Trial Compass
UnknownNot Applicable
Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage
Spain36 participantsStarted 2024-06
Plain-language 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 population with non-progressive brain damage. The main questions it aims to answer are:
* Does tDCS boost upper limb function rehabilitation results adding as an adjuvant in paediatric brain damage?
* What domains related with upper limb function are most influenced by tDCS stimulation?
* What clinical variables are the best to predict the efficacy of the combined treatment?
* If the selected intervention causes changes in cognitive domains, and, if it occurs, see their relationship with the proposed intervention and the motor outcomes.
As a general objective, this trial seeks the validation of a protocol of non-invasive brain stimulation with tDCS as a complementary therapy for peadiatric population with brain injuries.
Participants will be randomly allocated into two groups: experimental group will receive anodal tDCS plus upper limb rehabilitation gaming system rehabilitation and control group will receive sham tDCS plus rehabilitation gaming system for upper limb rehabilitation. Both groups will conducted a virtual reality program with upper limb exercises while been stimulated either with anodal tDCS or sham tDCS.
Researchers will compare experimental and control groups to see if there is a difference in upper limb function and cognitive functions.
Who can participate
Age range
7 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Melbourne Assessment 2 (MA-2)
Timeframe: From baseline at 2 weeks and 6 weeks
2
Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
Timeframe: From Baseline at 2 weeks and 6 weeks
3
Changes in kinematic and kinetic upper limb analysis - Movement acceleration
Timeframe: From Baseline at 2 weeks and 6 weeks
4
Changes in kinematic and kinetic upper limb analysis - Duration of the movement
Timeframe: From Baseline at 2 weeks and 6 weeks
5
Changes in kinematic and kinetic upper limb analysis - range of motion