IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT06372028 ((BOOSTTVNS)) para Paralisia cerebral está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) 44 Não invasivo Randomizado Adolescente
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06372028 ((BOOSTTVNS)) é um estudo intervencionista para Paralisia cerebral. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 15 de abril de 2024, com o objetivo de incluir 44 participantes. Coordenado por IRCCS Eugenio Medea e deve ser concluído em 14 de maio de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 17 de abril de 2024.
Resumo
The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-I...Mostrar mais
Descrição detalhada
This represents one of the two RCTs of the project "Bottom-up and tOp-down neuromOdulation of motor plaSTicity in cerebral palsy" (BOOST; FRRB 3438840). The study will be a randomized, sham controlled, pre-test/post-test study involving 44 children and adolescents with CP. Patients will be treated in pairs, with a matching of motor deficit severity, IQ, and age. Each pair will be randomly assigned to the active or to...Mostrar mais
Título oficial
tVNS-combined Motor Training for the Rehabilitation of the Upper Limb in Children and Young People With Cerebral Palsy: a Randomized, Sham-controlled Trial
Condições médicas
Paralisia cerebralPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- (BOOSTTVNS)
- 944/A
Número NCT
Data de início (real)
2024-04-15
Última atualização postada
2024-04-17
Data de conclusão (estimada)
2026-05-14
Inscrição (estimada)
44
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
transcutaneous Vagus Nerve Stimulation
intensive bimanual training
neurorehabilitation
non invasive brain stimulation
upper limb motor deficit
intensive bimanual training
neurorehabilitation
non invasive brain stimulation
upper limb motor deficit
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Triplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalActive tVNS combined with the training The active stimulation will be applied through an active electrode placed on the cymba conchae (the auricular branches of the vagus nerve) of the left ear. The intensity will be set based on the individual perceptual threshold, below the perception of pain. The intensity of the stimulation will be gradually increased in order to reach the intensity of stimulation with a ramping-up phase of 30 secs. The tVNS will be a...Mostrar mais | transcutaneous vagus nerve stimulation (tVNS) tVNS allows the non-invasive stimulation of the Vagus Nerve by delivering electrical pulses to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. TVNS seems to engage the same neural pathways of invasive VNS methods and may provide a novel, bottom-up NIBS method to enhance gamma-aminobutyric acid and Noradrenaline levels, which play a pivotal role in brain plas...Mostrar mais |
Comparador simuladoSham tVNS combined with the training The sham stimulation will be applied through an active electrode placed on lobe of the left ear that is free of cutaneous vagal innervations. The stimulation intensity will be set based on the individual perceptual threshold, below the perception of pain. The intensity of the stimulation will be gradually increased in order to reach the intensity of stimulation with a ramping-up phase of 30 secs. The tVNS will be app...Mostrar mais | transcutaneous vagus nerve stimulation (tVNS) tVNS allows the non-invasive stimulation of the Vagus Nerve by delivering electrical pulses to the sensory afferent fibers of the auricular, thick-myelinated, branch of the vagus nerve in the outer ear. TVNS seems to engage the same neural pathways of invasive VNS methods and may provide a novel, bottom-up NIBS method to enhance gamma-aminobutyric acid and Noradrenaline levels, which play a pivotal role in brain plas...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Assisting Hand Assessment (AHA) | This scale enables to quantify the assistance provided by the more affected hand to the less affected hand during bimanual activities. This observation-based, criterion-referenced assessment highlights a person's typical performance, emphasizing practical functionality over maximal capacity, and serves as a reliable measure of change over time. The scale comprised 20 items, scored on a 4-point Likert scale, from 1 to 4. The total score indicates how well the more affected hand is used as an assisting hand. A score of 20 means poor performance (the hand is not used as an assisting hand); a score of 80 means that the hand is used effectively. The results are converted for each of the three scales to logits by a Rasch analysis, on a 0-to-100 scale (with higher scores suggesting better use). | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Box and Block Test (BBT) | This test is designed to measure manual dexterity. It is quick, simple, and cost-effective. It involves a box with a partition in the middle placed on a table, with a total of 150 blocks on one side of the partition. The score of the test is given by the number of blocks transported within a minute. Higher values suggest better performance. The BBT provides a reliable and objective measurement of manual dexterity, making it valuable for evaluating functional outcomes and monitoring progress in rehabilitation programs over a short period of time. | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Visuomotor task | The visuomotor task is an ad hoc computer based task. It involves a mouse click-and-drag operation where an object appears at the center of the screen. The objective is to drag and drop the object to the location indicated by a previously presented arrow, pointing towards a target object within a configuration of objects. Participants are required to focus on the arrow's direction, swiftly and accurately moving the central object to its designated target location. This task enables the measurement of movement time (in milliseconds; consisting in the time necessary to move the object in the target position); precision error (calculated as the distance, in pixels, between the drop position of the object and the actual target position); the proportion of overtime errors (the percentage of trials in which responses are too slow). Smaller values of Movement time, Precision error and overtime errors will suggest better performance. | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Canadian Occupational Performance Measure (COPM) | This is a client-centered, semi-structured interview used in occupational therapy to identify the problems experienced by the patients. This interview engages the patient in recognizing daily occupations of importance that he/she want to do, need to do, or are expected to do but is unable to accomplish. Upon the identification of the problems experienced in patient's everyday-life activities, the patient is asked to rate the importance of each activity in his/her life though a 10-point rating scale and then, to select up to five problems to be addressed during the intervention. Lastly, the patient is asked to rate on a 10-point scale his/her own level of performance and satisfaction in performing that activity for each of the five problems (from 0, low performance or low satisfaction to 10, high performance or high satisfaction). | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Children's Hand-UseExperienceQuestionnaire (CHEQ) | The questionnaire includes 27 bimanual activities. Each activity is rated on three scales measuring: i) the perceived efficacy of the activity ("How do you think the child's hand works?") from 1 (Bad / not used hand) to 4 (Good efficacy); ii) the amount of assistance and the time needed to perform the activity ("How much time does your child need to do the whole task, compared to peers?) from 1 (Considerably longer) to 4 (Equally long time compared to other peers); and iii) the child's satisfaction with their performance ("Is your child bothered by his/her reduced hand/arm function during this activity?") from 1 ("It bothers him/her a lot") to 4 ( "It does not bother him/her at all"). The questionnaire provides a result corresponding to the summary of the ratings. The results are converted for each of the three scales to logits by a Rasch analysis, on a 0-to-100 scale (with higher scores suggesting better performance/satisfaction). | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Melbourne Assessment 2 (MA2) | This scale allows evaluating the unimanual performance of both the more and less affected hand. It measures four elements of upper limb movement quality: movement range, accuracy, dexterity and fluency. It consists of 14 test items that require children to interact (by reaching, grasping, releasing and manipulating) with simple objects. Movement elements are scored on a 3-, 4-, or -5 point scale according to specific criteria. Scores are arranged into the 4 sub-scales (movement range, accuracy, dexterity and fluency) according to the element of movement being rated. A child's total raw score for each sub-scale is converted to a percentage of the maximum possible score for that sub-scale, with higher scores indicating better performance. | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Gross Motor Function Measure (GMFM-66) | It is a standardized observational tool used by healthcare professionals to evaluate and quantify the gross motor abilities and limitations of children with CP. It assesses 66 motor skills across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Each skill is scored on a 4-point scale, ranging from 0 (does not initiate) to 3 (performs fully). | 1-2 days before the start of training (t0), 1-2 days after the end of the training (t1), three months after the end of the training (t2) |
Vineland Adaptive Behavior Scale Version 2 (VABS II) | This is a tool designed to assess adaptive behavior in individuals from birth to age 90. It assesses 11 subdomains of adaptive behavior grouped into four domains; sums of these scores are standardized into Communication, Daily Living Skills, Socialization and Motor Skills domain standard scores. Sums of the domain standard scores are then standardized into the Adaptive Behavior Composite score ranging from 20 to 160 (mean=100; standard deviation= 15). | 1-2 days before the start of training (t0), three months after the end of the training (t2) |
Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) | This is a widely employed, brief, and standardized self-reporting tool for assessing health-related quality of life in children and young individuals. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report) with versions available for children and young people aged 5-7, 8-12, and 13-18. Parent-rated versions are available for children aged 2-4, 5-7, 8-12, and 13-18. The versions from 5 to 18 years comprise 35 items comprising 7 dimensions: Daily Activities; School Activities; Movement and Balance; Pain and Hurt; Fatigue;Eating Activities; Speech and Communication. For each item, consisting in everyday life action, it is required to indicate how much of a problem each item has been in the past month with response options from 0 (never a problem) to 4 (almost always a problem). The items are reverse scored and transformed to a 0-100 scale, with higher scores indicating better health related quality of life. | 1-2 days before the start of training (t0), three months after the end of the training (t2) |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
6 Years
Sexos elegíveis
Todos
- clinical signs of unilateral or bilateral upper limb deficits (with a difference at least of 25% between more affected and less affected hand at Box and Block test);
- Magnetic Resonance Imaging (MRI) confirmed diagnosis according to Surveillance of Cerebral Palsy (SCPE) criteria;
- Manual Ability Classification System (MACS) level I,II,III;
- Gross Motor Function Classification System (GMFCS) level I,II,III;
- Visual Function Classification System (VFCS) I-II-III;
- Intelligence quotient (IQ) > 50.
- presence of cochlear implant, cardiac pacemaker, ventriculoperitoneal shunt, neuro-stimulators, clips, fragments or metal splinters in the brain or skull except for titanium;
- treatments for spasticity or functional surgery of the upper limb in the previous 6 months or planned during the duration of the study;
- uncontrolled epileptic seizure in the last 2 years.
IRCCS National Neurological Institute "C. Mondino" Foundation
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sem dados de contato.
1 Locais do estudo em 1 países
Lecco
Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, 23842, Italy
Alessandra Finisguerra, Contato, +39031877652, [email protected]
Cosimo Urgesi, Contato, [email protected]
Viola Oldrati, Subinvestigador