Neuromodulation of Social Skills in Childhood Ataxia

NCT ID: NCT04297540

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2023-02-15

Brief 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.

Detailed Description

The investigators planned a single centre, randomized stratified, double-blind, sham- controlled design.

Adolescents and young adults with childhood ataxia will be recruited and randomly assigned to two different groups: the active-tDCS group and the sham-tDCS group. Each group will undergo a multi-sessions (8 sessions) intervention during which tDCS will be delivered over the cerebellum. The stimulation will be paired with a virtual reality VR training. The Virtual Reality (VR) training will exploit a design based on probabilistic learning of social events in child-friendly environments. During the training, participants will be asked to conquer some goal/objects by predicting the behaviour of some competing virtual avatars whose actions should be probabilistically learned. Based on the same structures, two different child-friendly scenarios will be created and they will be respectively used in the pre- and in the post-training evaluation sessions (scenario A) or in association with the tDCS protocol throughout the 8 sessions of intervention (scenario B).

Participants' abilities of social prediction (primary outcome) will be tested through a validated computer based Action prediction task assessing participants' abilities in predicting others' actions based on previous experience. This experimental paradigm comprises a probabilistic learning (familiarization) phase and a testing phase. In the familiarization phase participants are asked to observe an actor performing two different types of grasping actions (such as grasping movement of an apple for eating the apple or for offering the apple to another partner) in different colour-cued contexts. They are asked to recognise actor's intention.

Crucially, the probability of co-occurrence between one action and the colour-cued context is implicitly biased with pre-established probability of association. In the testing phase, the same videos are presented but their length is dramatically shortened via temporal occlusion before the action is completed. In this way, since the movement kinematics is ambiguous, an observer would use the previously learned association with context to predict the fate of the action, and responses should be biased toward the contextual priors. A control non-social prediction task with a similar structure will be also used. A standard neuropsychological assessment (NEPSY-II) before and after the training will allow assessing the generalizability of the effects to general social perception abilities, in particular Theory of Mind and affect recognition (Secondary Outcomes). In the post-training and in the follow-up evaluation session (one month after the end of the intervention) the training acceptability and the quality of life assessments will be performed.

The protocol will allow testing the efficiency of the combined tDCS+ VR training in:

• enhancing social prediction abilities in childhood ataxia;
• enhancing implicit learning abilities, even in non social contexts;
• improving theory of mind abilities;
• improving patients' quality of life;
• further investigating the safety and tolerability of tDCS.

Conditions

Ataxia, Cerebellar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active-tDCS group

8 sessions (in two weeks) of active tDCS combined with a virtual reality training

Group Type: EXPERIMENTAL

Active-tDCS group

Intervention Type: DEVICE

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.

Sham-tDCS group

8 sessions (in two weeks) of sham tDCS combined with a virtual reality training

Group Type: SHAM_COMPARATOR

Sham-tDCS group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adolescents and young adults who aged 11-25 years
• Childhood ataxia
• Intelligence Quotient > 80

Exclusion Criteria

• Presence of contraindication to tDCS (history of epilepsy, migraine, severe brain trauma; presence of metal in the brain/skull or implanted neurostimulator, cardiac pacemaker; state of pregnancy)
• Intake of or withdrawal from some drugs potentially changing the seizure threshold
• Presence of comorbidity with an important medical conditions
• Severe sensorial, motor and/or behavioural problems that could interfere with the use of GRAIL/VR technology

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alessandra Finisguerra

Role: CONTACT

alessandra.finisguerra@lanostrafamiglia.it

+390432693111

Cosimo Urgesi

Role: CONTACT

cosimo.urgesi@uniud.it

Other Identifiers

742

Identifier Type: -

Identifier Source: org_study_id