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Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS)
Sponsor: IRCCS Eugenio Medea
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.
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
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-04-15
Completion Date
2026-05-14
Last Updated
2024-04-17
Healthy Volunteers
No
Conditions
Interventions
transcranial Alternating Current Stimulation
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.
Locations (1)
Scientific Institute, IRCCS E. Medea
Bosisio Parini, Lecco, Italy