Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-02
Brief Title:
Transcranial Alternating Current Stimulation in Cerebral Palsy BOOSTTACS
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
tACS-combined Motor Training for the Rehabilitation of the Upper Limb in Children and Young People With Cerebral Palsy a Randomized Sham-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOSTTACS
Brief Summary:
The present study aims to assess through a randomized controlled trial RCT the efficacy of transcranial alternating current stimulation tACS 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 tACS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities HABIT-ILE and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits The investigators hypothesized that thanks to the intensive bimanual training both the active and the sham group will improve in motor functioning However in light of findings showing that tACS effectively improves motor learning the investigators hypothesized that active tACS might improve in a greater and more lasting extent than sham tACS the motor functioning Moreover as suggested by previous studies investigating the effect of non-invasive brain stimulation NIBS in pediatric population the investigators expected that the treatment will be safe and well tolerated Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP
Detailed Description:
This represents one of the two RCTs of the project Bottom-up and tOp-down neuromOdulation of motor plaSTicity in cerebral palsy BOOST FRRB 3438840The study will be a randomized sham controlled pre-testpost-test study involving 44 children and adolescents with CP Patients will be treated in pairs with a matching of motor deficit severity IQ or age Each pair will be randomly assigned to the active or to the sham tACS group stratifying the pairs between the two groups based on motor deficit severity IQ or age Both groups will undergo a bimanual training in an ecological and highly motivating environment during the application of the tACS During the training starting from a set of proposals the choice of the type of activities to be practiced in each session will be left to patients boosting the motivational aspect of the training This will also ensure an individualized and goal directed approach The therapists will monitor and modify the activities within each pair to ensure that the intervention maintains the quality of the individualized intervention The positions performed during bimanual tasks and the activities of daily living will be designed to systematically engage postural control of the trunk and lower limbs according to Habit-ILE protocol The rehabilitation treatment will be carried out for 5 consecutive days for 3hday for 2 weeks 30 hours of intervention overall Children and adolescents will be assessed before the start of treatment T0 immediately after the end of intensive treatment T1 and three months after the end T2 The overall RCT will be structured as follows In the first session prior the beginning of the training t0 the RCT will include the administration of all clinical assessment measures and the patients will be asked to perform for 10 minutes an ad-hoc computer based Visuomotor task please refer to the outcome sessions for more detailed description Cortical rhythms will be recorded by electroencephalogram EEG both before during rest and during the execution of the Visuomotor task Analysis of the resting-state EEG will be conducted to derive the Individualized Gamma Frequency IGF which will be matched to each patients specific stimulation frequency delivered through tACS during the training Patients will undergo the 10 days treatment For each training day the treatment will last three hours During the first 20 minutes of treatment the active or sham tACS according to the group allocation will be delivered Before starting and 20 minutes after the end of the stimulation the vital parameters will be checked After the end of the stimulation patients will be also asked to rate the sensations experienced during the stimulation through Visual Analogue Scales and through child-friendly Likert scales Then they will continue the training for the remaining session time without stimulation Soon after the end of all the training sessions patients will carry the t1 evaluation As for the t0 session this session will include the administration of the clinical assessment measures and execution for 10 minutes of the Visuomotor task Three months after the end of the training t2 the follow up assessment will be conducted following the same exact procedure of t0
Primary outcomes will include the following clinical measures the Assisting Hand Assessment AHA the Box and Block Test BBT and the performance at the Visuomotor task Secondary outcome will include the scores at the following tests the Childrens Hand Experience Questionnaire CHEQ the Canadian Occupational Performance Measure COPM the Gross Motor Function Measure GMFM-66 the Melbourne Assessment-2 MA2 scale the Vineland Adaptive Behavior Scale Version 2 VABS 2 the Pediatric Quality of Life Inventory PEDS-QL and the cortical rhythms registered via EEG at rest and during the Visuomotor task Vital parameters the oxygen saturation SPO2 and the Heart Rate HR and the scores at the questionnaires assessing stimulation- induced sensations will be also checked to assess the safety and the tolerability of the stimulation Lastly the feasibility and the acceptability of the training will be assessed by considering respectively the number of patients completing the trainingthe number of sessions for each patient and the response to ad hoc questionnaires for the patients and their guardians
All primary and secondary outcomes will be collected at each time point except for the PedsQL and VABS-II that will be administered only at T0 and T2 Furthermore vital parameters and the questionnaires assessing stimulation-induced sensations will be examined during each stimulation session The acceptability questionnaires will be administered only after the end of the training t1
The patients and their guardians the personnel responsible for conducting the bimanual training and analysing clinical data will be kept blind to the group allocation Instead the coordinator of the study the staff who will apply the tACS will be not blind With respect to the clinical assessment whenever possible the staff administering and scoring the scales will be blinded to group allocation Questionnaire scores and neuropsychological tests will not contain personal information about the subjects who will be identified by an alphanumeric code All records that contain names or other personal identifiers such as informed consent forms will be stored separately from study records identified by code number In order to uphold the overall quality of the clinical trial instances of code breaks should be limited to exceptional circumstances where knowledge of the actual treatment is deemed absolutely necessary for the ongoing management of the patient
The intensive treatment will take place at IRCCS E Medea Associazione La Nostra Famiglia in Bosisio Parini Lecco at Fondazione Mondino IRCCS Pavia and at ASST Ospedali Civili di Brescia
This trial is supported by Fondazione Regionale per la Ricerca Biomedica Regione Lombardia project FRRB 3438840 BOOST Bottom-up and tOp-down neuromOdulation of motor plaSTicity in cerebral palsy
Primary outcomes will include the following clinical measures the Assisting Hand Assessment AHA the Box and Block Test BBT and the performance at the Visuomotor task Secondary outcome will include the scores at the following tests the Childrens Hand Experience Questionnaire CHEQ the Canadian Occupational Performance Measure COPM the Gross Motor Function Measure GMFM-66 the Melbourne Assessment-2 MA2 scale the Vineland Adaptive Behavior Scale Version 2 VABS 2 the Pediatric Quality of Life Inventory PEDS-QL and the cortical rhythms registered via EEG at rest and during the Visuomotor task Vital parameters the oxygen saturation SPO2 and the Heart Rate HR and the scores at the questionnaires assessing stimulation- induced sensations will be also checked to assess the safety and the tolerability of the stimulation Lastly the feasibility and the acceptability of the training will be assessed by considering respectively the number of patients completing the trainingthe number of sessions for each patient and the response to ad hoc questionnaires for the patients and their guardians
All primary and secondary outcomes will be collected at each time point except for the PedsQL and VABS-II that will be administered only at T0 and T2 Furthermore vital parameters and the questionnaires assessing stimulation-induced sensations will be examined during each stimulation session The acceptability questionnaires will be administered only after the end of the training t1
The patients and their guardians the personnel responsible for conducting the bimanual training and analysing clinical data will be kept blind to the group allocation Instead the coordinator of the study the staff who will apply the tACS will be not blind With respect to the clinical assessment whenever possible the staff administering and scoring the scales will be blinded to group allocation Questionnaire scores and neuropsychological tests will not contain personal information about the subjects who will be identified by an alphanumeric code All records that contain names or other personal identifiers such as informed consent forms will be stored separately from study records identified by code number In order to uphold the overall quality of the clinical trial instances of code breaks should be limited to exceptional circumstances where knowledge of the actual treatment is deemed absolutely necessary for the ongoing management of the patient
The intensive treatment will take place at IRCCS E Medea Associazione La Nostra Famiglia in Bosisio Parini Lecco at Fondazione Mondino IRCCS Pavia and at ASST Ospedali Civili di Brescia
This trial is supported by Fondazione Regionale per la Ricerca Biomedica Regione Lombardia project FRRB 3438840 BOOST Bottom-up and tOp-down neuromOdulation of motor plaSTicity in cerebral palsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None