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Neuromodulation of Social Skills in Childhood Ataxia

NCT04297540 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-05

No results posted yet for this study

Summary

The present study aims to define a protocol of electrical stimulation of the cerebellum via transcranial direct current stimulation (tDCS) combined with a virtual reality protocol to assist the rehabilitation of social skills in adolescents and young adults with childhood ataxia.

Taking into account the high neuronal density of the cerebellum, its strong connection with the cerebral cortex, and its involvement in motor, cognitive and affective processes, as well its involvement in social prediction abilities, the investigators hypothesized that excitatory stimulation of the cerebellum might improve social prediction abilities in adolescents and young adults with childhood ataxia. Moreover, as suggested by previous studies investigating the effect of tDCS in paediatric population, the investigators expected that tDCS will be safe and well tolerated. Such a result would encourage the use of non-invasive brain stimulation in the rehabilitation of social skills in childhood ataxia.

Conditions

  • Ataxia, Cerebellar

Interventions

DEVICE

Active-tDCS group

Active anodal-tDCS will be delivered over the cerebellum for 8 sessions in two weeks. tDCS will be delivered via a battery driven direct current stimulator. Saline-soaked sponges electrodes will be placed on the cerebellar vermis (anodal electrode) and over the right buccinator muscle (reference electrode). Stimulation intensity will be set at 1.5 mA. The intensity of the stimulation will be gradually increase in order to reach the 1.5 mA with a ramping-up phase of 15 sec. Similarly, a ramping-down phase of 15 sec will gradually decrease the intensity before the end of the stimulation. The duration of the 1.5mA stimulation will be 20 minutes. Soon after the end of the stimulation, the virtual reality training will be performed. The virtual reality training will took place in a child-friendly scenario. It will comprise a total of 80 trials, during which participants will be asked to compete with some avatars in order to activate and to win some objects.

DEVICE

Sham-tDCS group

Sham -tDCS will be delivered over the cerebellum for 8 sessions in two weeks. tDCS will be delivered via a battery driven direct current stimulator. Saline-soaked sponges electrodes will be placed on the cerebellar vermis (anodal electrode) and over the right buccinator muscle (reference electrode). Stimulation intensity will be set at 1.5 mA but the current will be applied for 30 sec. The intensity of the stimulation will be gradually increase in order to reach the 1.5 mA with a ramping-up phase of 15 sec. Similarly, a ramping-down phase of 15 sec will gradually decrease the intensity before the end of the stimulation. The duration of the 0mA stimulation will be 20 minutes. Soon after the end of the stimulation, the virtual reality training will be performed. The virtual reality training will took place in a child-friendly scenario. It will comprise a total of 80 trials, during which participants will be asked to compete with some avatars in order to activate and to win some objects.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-12-31
Completion
2023-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04297540 on ClinicalTrials.gov