Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS)

NCT06372041 | Not Yet Recruiting

• 1 other identifier: 944/B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

transcranial Alternating Current Stimulation; intensive bimanual training; neurorehabilitation; non invasive brain stimulation; upper limb motor deficit

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (7)

• Canadian Occupational Performance Measure (COPM)

  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-Use Experience Questionnaire (CHEQ)

  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)

  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)

  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)

  1-2 days before the start of training (t0), three months after the end of the training (t2)

Other Outcomes (6)

• Heart rate (HR)

  in the first 2 minutes and after 20 minutes of stimulation session

• Oxygen saturation (SPO2)

  in the first 2 minutes and after 20 minutes of stimulation session

• Tolerability of the stimulation

  immediately after every stimulation sessions of the 10-days training

Study Arms (2)

Active tACS combined with the training

EXPERIMENTAL

The tACS will be applied for the first 20 minutes of the training, every day of the treatment. Before and the after of the stimulation, SpO2 and HR will be checked. After the stimulation participants will be asked to rate the sensations and possible side effects occurring during tACS. The intensive bimanual training will be administered by following the procedure described in the Detailed Description session, as for the Sham tACS combined with the training arm.

Device: transcranial Alternating Current Stimulation

Sham tACS combined with the training

SHAM COMPARATOR

The sham-tACS will be applied for the first 20 minutes of the training, every day of the treatment. However, in this condition, after the initial 30 seconds of ramp-up phase of the current, the stimulation will be switched off. This procedure allows participants to feel the characteristic tingling sensations in the vicinity of the electrodes for a brief period of time, which enhanced the plausibility of the sham condition.Before and the after of the stimulation, SpO2 and HR will be checked. After 20 minutes from setting-up the stimulation, participants will be asked to report the sensations and possible side effects occurring during tACS and to rate their feeling on several visual analogue scales and Likert scales. The intensive bimanual training will be administered by following the procedure described in the Detailed Description session, as for the Sham tACS combined with the training arm.

Device: transcranial Alternating Current Stimulation

Interventions

transcranial Alternating Current Stimulation DEVICE

tACS will be performed by using a Conformite Europeenne (CE) marked stimulator device (Starstim ®, Neuroelectrics, Barcelona, Spain). By applying alternating current at the gamma frequency band (range 30-80), known to be associated to motor performance, tACS can entrain or synchronize neural oscillations in the targeted brain regions. By modulating cortical excitability of the cerebellum, a region strongly involved in motor learning and coordination, tACS is expected to influence the strength and coordination of motor responses elicited during the training. tACS will be delivered through two saline-soaked surface sponge electrodes (dimension: 25cm2 each), one placed over F3 (left frontal region) and the other over the right cerebellar hemisphere. The intensity will be set to 1mA, and this value will be gradually reached with a ramping-up phase of 30 secs. The frequency of the stimulation will match the IGF identified during the EEG recording performed at rest.

Active tACS combined with the training; Sham tACS combined with the training

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator

Study Sites (1)

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (2)

• Vacchini V, Brafa B, Nicotra R, Capelli E, Signorini S, Gasparroni V, Michelutti A, Oldrati V, Galli J, Urgesi C, Cattaneo Z, Fazzi EM, Borgatti R, Finisguerra A, Orcesi S; Boost Working Group. Improving neuroplasticity and Quality of Life in children with Cerebral Palsy: a customized intensive motor training protocol integrating the HABIT-ILE approach. Front Rehabil Sci. 2025 Oct 13;6:1613103. doi: 10.3389/fresc.2025.1613103. eCollection 2025.

  PMID: 41158535 DERIVED

• Oldrati V, Ciricugno A, Borgatti R, Orcesi S, Fazzi E, Galli J, Gasparroni V, Piccinini L, Maghini C, Cattaneo Z, Arioli M, Urgesi C, Finisguerra A. tACS-combined motor training for the rehabilitation of the upper limb in children and adolescents with cerebral palsy: A randomized, sham-controlled trial protocol. PLoS One. 2025 Sep 3;20(9):e0331360. doi: 10.1371/journal.pone.0331360. eCollection 2025.

  PMID: 40901773 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 17, 2024
• Study Start: April 15, 2024
• Primary Completion: March 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Before data analyses, for ten years.
• Access Criteria: all

Locations

IT (1)