Paediatric Brain DamageNCT06214364
Transcranial Direct Current Stimulation and Gamified Rehabilitation for Upper Limb Function in Pediatric Brain Damage
A study testing Active Transcranial Direct Current Stimulation in people with Paediatric Brain Damage and Cerebral Palsy, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Paediatric Brain Damage, Cerebral Palsy, Paediatric Stroke
- What is being tested?
- Active Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation as Adjuvant to Gamified Rehabilitation for Upper Limb Function in Pediatric Non-progressive Brain Damage: a Randomized Controlled Trial
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.
Read more
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.
Read the 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 early years of life, and acquired paediatric brain damage, which encompasses sudden brain injuries occurring after birth, stemming from various causes such as traumatic brain injuries, strokes, infections, and brain tumors. Cerebral palsy is estimated to affect 2 cases per 1,000 births, while acquired childhood brain damage exhibits variable incidences depending on the cause. Both categories manifest a broad spectrum of symptoms, ranging from motor and sensory impairments to cognitive, behavioral, and emotional issues, necessitating a transdisciplinary rehabilitation approach. Neuroplasticity has an essential role in function developing and recovery, because of that several rehabilitation techniques are based on this concept, such as virtual reality. Non-invasive brain stimulation is developed to enhance these neuroplasticity mechanisms and, used as a coadjuvant therapy, seeks to get greater and faster results from rehabilitation treatments. Specifically transcranial direct current stimulation (tDCS) has shown positive results in motor functions like gait, balance and upper limb function, when applied as anodal tDCS over M1 cortex. The aim of this study is to conduct an independent parallel randomized trial to assess the effectiveness of tDCS combined with virtual reality in paediatric brain damage in upper limb function, as well as study if the stimulation conducted in M1 cortex has influenced in another cerebral areas and therefore causes changes in cognitive functioning such as executive functions and attention.
- Conditions
- Paediatric Brain Damage, Cerebral Palsy, Paediatric Stroke, Paediatric Traumatic Brain Injury, Paediatric Acquired Brain Injury
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Keywords
- tDCS, NIBS, Virtual reality, Upper limb function, Paediatric brain damage, Cerebral palsy, Paediatric stroke, Paediatric acquired brain injury
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
Active Anodal Transcranial Direct Current Stimulation (a-tDCS) will be applied over the Primary Motor Cortex of the affected or most affected hemisphere during 10 20 minute-sessions at 2 miliamps.
The tDCS stimulator device will be used by an experienced physical therapist by a saline-soak pair of surface electrodes. The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1.
While the tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation.
Sham Transcranial Direct Current StimulationDevice
The electrodes will be placed in the same position as for the Primary Motor Cortex stimulation, as in the experimental group. Current will be applied for 30 seconds in the beginning and at the end for securing the blinding.
While the sham tDCS stimulation is administered virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Active Anodal Transcranial Direct Current Stimulation (a-tDCS) will be applied over the Primary Motor Cortex of the affected or most affected hemisphere during 10 20 minute-sessions at 2 miliamps.
The tDCS stimulator device will be used by an experienced physical therapist by a saline-soak pair of surface electrodes. The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1.
While the tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation. Receives: Device: Active Transcranial Direct Current Stimulation |
| Sham Transcranial Direct Current Stimulation | Sham comparator | Sham Transcranial Direct Current (s-tDCS) will be applied over the Primary Motor Cortex during 10 sessions of 20 minutes.
The electrodes will be placed in the same positioned as for M1 stimulation in the experimental group, but the current will only be applied ramping for 30 seconds in the beginning and at the end of the procedure to secure the blinding.
While the sham tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the sham tDCS stimulation. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Melbourne Assessment 2 (MA-2)
Upper limb functionality scale for children with neurological impairment from 2,5 to 15 years. It evaluates range of movement, target accuracy, fluency, grasp, accuracy of release, finger dexterity and speed. These elements are scored separately based on the execution of 16 different activities, giving a 0 to 4 or 0 to 3 punctuation in 36 different items.
Measured: From baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).
The analysis will include mean and peak velocity of the movement, addressed in meters per second (m/s).
Measured: From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Movement acceleration
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).
The analysis will include movement acceleration, addressed in meters per second squared (m/s^2).
Measured: From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - Duration of the movement
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The time parameters included in the analyses will be: going phase, adjusting phase, returning phase and total movement duration. All measures will be addressed in seconds (s).
Measured: From Baseline at 2 weeks and 6 weeks
Changes in kinematic and kinetic upper limb analysis - range of motion
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France).
The analysis will include range of motion of flex-extension of shoulder, elbow and wrist; horizontal abduction of the shoulder, radial and cubital deviation of the wrist and abduction and adduction of the shoulder. The markers needed to register the movement will be place according to Wu et al. protocol in sternocostoclavicular joints and xiphoid process for the trunk, acromioclavicular joint for the shoulder, medial and lateral epicondyles for the elbow, radial and ulnar styloid processes for the wrist and heads of the second and fourth metacarpals for the hand.
These measures will be addressed in degrees.
Measured: From Baseline at 2 weeks and 6 weeks
Changes in Box and Block Test (BBT)
This test assesses dexterity. It consists of placing the greater number of cubes from one place to another in 60 seconds.
Measured: From baseline at 2 weeks and 6 weeks
Secondary outcomes (12)
Changes in and grip strength
Hand grip strength will be evaluated with a dynamometer
Measured: From baseline at 2 weeks and 6 weeks
Changes in finger flexor muscles spasticity
Finger flexor muscle groups spasticity will be evaluated by AMADEO device (Tyromotion, Graz). The device assesses spasticity in the flexor muscle groups of the fingers based on the modified Ashworth scale (MAS), taking 3 measurements at 3 different speeds.
Measured: From baseline at 2 weeks and 6 weeks
Changes in finger extensor muscles spasticity
Finger extensor muscle groups spasticity will be evaluated by AMADEO device (Tyromotion, Graz). The device assesses spasticity in the extensor muscle groups of the fingers based on the modified Ashworth scale (MAS), taking 3 measurements at 3 different speeds.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Children's hand-use experience questionnaire (CHEQ)
Measures Upper limb use in daily living activities and its subjective experience using the affected hand in activities where usually two hands are needed. This questionnaire can be answered by the children or the caregivers. It has 3 categories: hand use, time needed to complete the action in comparison with their equals and personal experience while conducting the action. It includes 27 different activities.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Wechsler Intelligence Scale for Children V (WISC-V)
Clinical instrument to assess intelligence in children from 6 to 16 years and 11 months. It provides scores of primary intelligence indices that reflect intellectual functioning in different cognitive areas: verbal comprehension, visuospatial ability, fluid reasoning, working memory, and processing speed. It also provides an overall intelligence score.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
This tool is a visual perception test which consists of a sequence of geometric figures, in ascending grade of complexity, to evaluate the visuomotor integration in individuals from 3 years to 17 years and 11 months old.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Neuropsychological battery for children NEPSY-II
It is a tool for conducting specific cognitive assessment by domains, from 3 to 16 years old, as it includes tests that assess attention and executive functions, language, memory and learning, sensorimotor functioning, visuospatial processing, and social perception.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Test of Everyday Attention for Children (TEA-Ch) Changes in Test for everyday attention for children (TEA-Ch)
This test evaluates the different types of attention (selective, divided and sustained) in visual and auditive modality for children between 6 and 12 years. It is composed of 9 subtests.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Verbal learning test for children Spain-Complutense (TAVECI)
This test is designed for evaluating memory and learning system in children between 3 and 16 years of age.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Behavior rating inventory for executive function 2 (BRIEF-2)
This is the international reference tool for assessing executive functioning for children between 5 and 18 years. It is reported from the parents, caregivers and teachers by questionnaires.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Evaluation System for children and adolescents (SENA)
This tool assesses a wide spectrum of emotional and conduct problems for children from 3 years to 18 through information of their environment.
Measured: From baseline at 2 weeks and 6 weeks
Changes in Kidscreen-52 scale
It is a quality of life questionnaire that is completed both by the children and by their parents or caregivers. It includes several domains about situations and functions of the daily living, answering the questions with a punctuation from 1 to 5. The final score is obtained by summing each value: higher values correlate with a good quality of life perception and lower punctuations correlate with a poor quality of life perception.
Measured: From baseline at 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Paediatric Brain DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is parallel randomized triple-blind controlled trial with two groups: experimental group will be administered active anodal tDCS and control group, with sham tDCS.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia, Hospital Beata María Ana
- Responsible party
- Sponsor
- Investigators
- Juan Pablo Romero Muñoz, PhD, MD, Principal investigator, Universidad Francisco de VitoriaMarcos Ríos Lago, PhD, Principal investigator, Universidad Nacional de Educación a DistanciaBeatriz Gavilán Agustí, PhD, Principal investigator, Hospital Beata María Ana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214364
- Sponsor's protocol ID
- CHILDBOOST
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized participant data will be available to other researchers under request.
Publications
Upadhyay J, Tiwari N, Ansari MN. Cerebral palsy: Aetiology, pathophysiology and therapeutic interventions. Clin Exp Pharmacol Physiol. 2020 Dec;47(12):1891-1901. doi: 10.1111/1440-1681.13379. Epub 2020 Aug 19.
PubMed 32662125Araki T, Yokota H, Morita A. Pediatric Traumatic Brain Injury: Characteristic Features, Diagnosis, and Management. Neurol Med Chir (Tokyo). 2017 Feb 15;57(2):82-93. doi: 10.2176/nmc.ra.2016-0191. Epub 2017 Jan 20.
PubMed 28111406Gmelig Meyling C, Verschuren O, Rentinck IR, Engelbert RHH, Gorter JW. Physical rehabilitation interventions in children with acquired brain injury: a scoping review. Dev Med Child Neurol. 2022 Jan;64(1):40-48. doi: 10.1111/dmcn.14997. Epub 2021 Jul 26.
PubMed 34309829Khan F, Amatya B, Galea MP, Gonzenbach R, Kesselring J. Neurorehabilitation: applied neuroplasticity. J Neurol. 2017 Mar;264(3):603-615. doi: 10.1007/s00415-016-8307-9. Epub 2016 Oct 24.
PubMed 27778158Choi JY, Yi SH, Ao L, Tang X, Xu X, Shim D, Yoo B, Park ES, Rha DW. Virtual reality rehabilitation in children with brain injury: a randomized controlled trial. Dev Med Child Neurol. 2021 Apr;63(4):480-487. doi: 10.1111/dmcn.14762. Epub 2020 Dec 16.
PubMed 33326122Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.
PubMed 28632467Ko EJ, Hong MJ, Choi EJ, Yuk JS, Yum MS, Sung IY. Effect of Anodal Transcranial Direct Current Stimulation Combined With Cognitive Training for Improving Cognition and Language Among Children With Cerebral Palsy With Cognitive Impairment: A Pilot, Randomized, Controlled, Double-Blind, and Clinical Trial. Front Pediatr. 2021 Aug 25;9:713792. doi: 10.3389/fped.2021.713792. eCollection 2021.
PubMed 34513765Collange-Grecco LA, Cosmo C, Silva ALS, Rizzutti S, Oliveira CS, Muszkat M. Effects of Dual Task Training and Transcranial Direct Current Stimulation in Children with Spastic Cerebral Palsy: A Pilot Randomized Control Trial. Dev Neurorehabil. 2023 Jul;26(5):279-286. doi: 10.1080/17518423.2023.2228400. Epub 2023 Jun 23.
PubMed 37352444
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as Adjuvant to Gamified Rehabilitation for Upper Limb Function in Pediatric Non-progressive Brain Damage: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06214364
- Acronym / sponsor ID
- CHILDBOOST
- Conditions
- Paediatric Brain Damage, Cerebral Palsy, Paediatric Stroke, Paediatric Traumatic Brain Injury, Paediatric Acquired Brain Injury
- Keywords
- tDCS, NIBS, Virtual reality, Upper limb function, Paediatric brain damage, Cerebral palsy, Paediatric stroke, Paediatric acquired brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- Universidad Nacional de Educación a Distancia, Hospital Beata María Ana
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 early years of life, and acquired paediatric brain damage, which encompasses sudden brain injuries occurring after birth, stemming from various causes such as traumatic brain injuries, strokes, infections, and brain tumors. Cerebral palsy is estimated to affect 2 cases per 1,000 births, while acquired childhood brain damage exhibits variable incidences depending on the cause. Both categories manifest a broad spectrum of symptoms, ranging from motor and sensory impairments to cognitive, behavioral, and emotional issues, necessitating a transdisciplinary rehabilitation approach. Neuroplasticity has an essential role in function developing and recovery, because of that several rehabilitation techniques are based on this concept, such as virtual reality. Non-invasive brain stimulation is developed to enhance these neuroplasticity mechanisms and, used as a coadjuvant therapy, seeks to get greater and faster results from rehabilitation treatments. Specifically transcranial direct current stimulation (tDCS) has shown positive results in motor functions like gait, balance and upper limb function, when applied as anodal tDCS over M1 cortex. The aim of this study is to conduct an independent parallel randomized trial to assess the effectiveness of tDCS combined with virtual reality in paediatric brain damage in upper limb function, as well as study if the stimulation conducted in M1 cortex has influenced in another cerebral areas and therefore causes changes in cognitive functioning such as executive functions and attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is parallel randomized triple-blind controlled trial with two groups: experimental group will be administered active anodal tDCS and control group, with sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| Active transcranial direct current stimulation | Active comparator | Device: Active Transcranial Direct Current StimulationActive Anodal Transcranial Direct Current Stimulation (a-tDCS) will be applied over the Primary Motor Cortex of the affected or most affected hemisphere during 10 20 minute-sessions at 2 miliamps. The tDCS stimulator device will be used by an experienced physical therapist by a saline-soak pair of surface electrodes. The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1. While the tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation. |
| Sham Transcranial Direct Current Stimulation | Sham comparator | Device: Sham Transcranial Direct Current StimulationSham Transcranial Direct Current (s-tDCS) will be applied over the Primary Motor Cortex during 10 sessions of 20 minutes. The electrodes will be placed in the same positioned as for M1 stimulation in the experimental group, but the current will only be applied ramping for 30 seconds in the beginning and at the end of the procedure to secure the blinding. While the sham tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the sham tDCS stimulation. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Direct Current StimulationActive Anodal Transcranial Direct Current Stimulation (a-tDCS) will be applied over the Primary Motor Cortex of the affected or most affected hemisphere during 10 20 minute-sessions at 2 miliamps. The tDCS stimulator device will be used by an experienced physical therapist by a saline-soak pair of surface electrodes. The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1. While the tDCS stimulation is administered, virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation. | Device | Active transcranial direct current stimulation |
| Sham Transcranial Direct Current StimulationThe electrodes will be placed in the same position as for the Primary Motor Cortex stimulation, as in the experimental group. Current will be applied for 30 seconds in the beginning and at the end for securing the blinding. While the sham tDCS stimulation is administered virtual reality upper limb exercises will be conducted. Virtual reality program will continue for another 20 minutes after the tDCS stimulation. | Device | Sham Transcranial Direct Current Stimulation |
Primary outcome
Changes in Melbourne Assessment 2 (MA-2)
Time frame: From baseline at 2 weeks and 6 weeks
Upper limb functionality scale for children with neurological impairment from 2,5 to 15 years. It evaluates range of movement, target accuracy, fluency, grasp, accuracy of release, finger dexterity and speed. These elements are scored separately based on the execution of 16 different activities, giving a 0 to 4 or 0 to 3 punctuation in 36 different items.
Changes in kinematic and kinetic upper limb analysis - Velocity of the movement
Time frame: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include mean and peak velocity of the movement, addressed in meters per second (m/s).
Changes in kinematic and kinetic upper limb analysis - Movement acceleration
Time frame: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include movement acceleration, addressed in meters per second squared (m/s^2).
Changes in kinematic and kinetic upper limb analysis - Duration of the movement
Time frame: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The time parameters included in the analyses will be: going phase, adjusting phase, returning phase and total movement duration. All measures will be addressed in seconds (s).
Changes in kinematic and kinetic upper limb analysis - range of motion
Time frame: From Baseline at 2 weeks and 6 weeks
The activities included in the MA-2 will be recorded with three different cameras: one in the frontal plane, another in the sagittal plane, and another for the transverse plane. Movement analysis will be carried out with the software kinovea (Kinovea, France). The analysis will include range of motion of flex-extension of shoulder, elbow and wrist; horizontal abduction of the shoulder, radial and cubital deviation of the wrist and abduction and adduction of the shoulder. The markers needed to register the movement will be place according to Wu et al. protocol in sternocostoclavicular joints and xiphoid process for the trunk, acromioclavicular joint for the shoulder, medial and lateral epicondyles for the elbow, radial and ulnar styloid processes for the wrist and heads of the second and fourth metacarpals for the hand. These measures will be addressed in degrees.
Changes in Box and Block Test (BBT)
Time frame: From baseline at 2 weeks and 6 weeks
This test assesses dexterity. It consists of placing the greater number of cubes from one place to another in 60 seconds.
12 secondary outcomes
Changes in and grip strength
Time frame: From baseline at 2 weeks and 6 weeks
Changes in finger flexor muscles spasticity
Time frame: From baseline at 2 weeks and 6 weeks
Changes in finger extensor muscles spasticity
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Children's hand-use experience questionnaire (CHEQ)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Wechsler Intelligence Scale for Children V (WISC-V)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Neuropsychological battery for children NEPSY-II
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Test of Everyday Attention for Children (TEA-Ch) Changes in Test for everyday attention for children (TEA-Ch)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Verbal learning test for children Spain-Complutense (TAVECI)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Behavior rating inventory for executive function 2 (BRIEF-2)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Evaluation System for children and adolescents (SENA)
Time frame: From baseline at 2 weeks and 6 weeks
Changes in Kidscreen-52 scale
Time frame: From baseline at 2 weeks and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 32662125Upadhyay J, Tiwari N, Ansari MN. Cerebral palsy: Aetiology, pathophysiology and therapeutic interventions. Clin Exp Pharmacol Physiol. 2020 Dec;47(12):1891-1901. doi: 10.1111/1440-1681.13379. Epub 2020 Aug 19.
- Background: PubMed 28111406Araki T, Yokota H, Morita A. Pediatric Traumatic Brain Injury: Characteristic Features, Diagnosis, and Management. Neurol Med Chir (Tokyo). 2017 Feb 15;57(2):82-93. doi: 10.2176/nmc.ra.2016-0191. Epub 2017 Jan 20.
- Background: PubMed 34309829Gmelig Meyling C, Verschuren O, Rentinck IR, Engelbert RHH, Gorter JW. Physical rehabilitation interventions in children with acquired brain injury: a scoping review. Dev Med Child Neurol. 2022 Jan;64(1):40-48. doi: 10.1111/dmcn.14997. Epub 2021 Jul 26.
- Background: PubMed 27778158Khan F, Amatya B, Galea MP, Gonzenbach R, Kesselring J. Neurorehabilitation: applied neuroplasticity. J Neurol. 2017 Mar;264(3):603-615. doi: 10.1007/s00415-016-8307-9. Epub 2016 Oct 24.
- Background: PubMed 33326122Choi JY, Yi SH, Ao L, Tang X, Xu X, Shim D, Yoo B, Park ES, Rha DW. Virtual reality rehabilitation in children with brain injury: a randomized controlled trial. Dev Med Child Neurol. 2021 Apr;63(4):480-487. doi: 10.1111/dmcn.14762. Epub 2020 Dec 16.
- Background: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Background: PubMed 28632467Moura RCF, Santos C, Collange Grecco L, Albertini G, Cimolin V, Galli M, Oliveira C. Effects of a single session of transcranial direct current stimulation on upper limb movements in children with cerebral palsy: A randomized, sham-controlled study. Dev Neurorehabil. 2017 Aug;20(6):368-375. doi: 10.1080/17518423.2017.1282050. Epub 2017 Feb 25.
- Background: PubMed 34513765Ko EJ, Hong MJ, Choi EJ, Yuk JS, Yum MS, Sung IY. Effect of Anodal Transcranial Direct Current Stimulation Combined With Cognitive Training for Improving Cognition and Language Among Children With Cerebral Palsy With Cognitive Impairment: A Pilot, Randomized, Controlled, Double-Blind, and Clinical Trial. Front Pediatr. 2021 Aug 25;9:713792. doi: 10.3389/fped.2021.713792. eCollection 2021.
- Background: PubMed 37352444Collange-Grecco LA, Cosmo C, Silva ALS, Rizzutti S, Oliveira CS, Muszkat M. Effects of Dual Task Training and Transcranial Direct Current Stimulation in Children with Spastic Cerebral Palsy: A Pilot Randomized Control Trial. Dev Neurorehabil. 2023 Jul;26(5):279-286. doi: 10.1080/17518423.2023.2228400. Epub 2023 Jun 23.
- Individual participant dataSharing planned: Yes. Individual anonymized participant data will be available to other researchers under request.
Related trials for Paediatric Brain Damage
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 3
Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy
Cerebral Palsy, Hip Surgery Corrective
Recruiting
Acceptability of Paediatric Wrist Orthoses Through Co-design
Cerebral Palsy (CP), Brain Injuries
Enrolling by invitationObservational study
Age Related Thresholds for Management of Severe Head Injury in Paediatrics: An Extension of STARSHIP
Traumatic Brain Injury, Pediatric
Active, not recruitingObservational study
Prognostic Model for Predicting Outcome After Moderate to Severe Paediatric Traumatic Brain Injury
Traumatic Brain Injury (TBI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Pablo Romero Muñoz, PhD, MD principal investigator
Universidad Francisco de Vitoria
Marcos Ríos Lago, PhD principal investigator
Universidad Nacional de Educación a Distancia
Beatriz Gavilán Agustí, PhD principal investigator
Hospital Beata María Ana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation in people with Paediatric Brain Damage and Cerebral Palsy, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Pablo Romero Muñoz, PhD, MD (+34 91 409 09 03, p.romero.prof@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Melbourne Assessment 2 (MA-2) (time frame: From baseline at 2 weeks and 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214364, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.