Neuromodulation of Social Skills in Childhood Ataxia
Neuromodulation Technique for the Rehabilitation of Social Skills in Childhood Ataxia
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedMarch 5, 2020
March 1, 2020
2.8 years
February 24, 2020
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Social Prediction abilities in the Action Prediction task
-Performance in the testing phase of the action prediction task, consisting in the accuracy in discriminating between two alternatives in order to predict the unfolding of an individual or interpersonal action as a function of different probability of co-occurence between the same action and a contextual cues, as previously learned during a familiarization phase.
Time 1- at the end the last training session vs Time 0- before starting the first training session
Change in Social Prediction abilities in the Virtual Reality scenario
-Performance in the evaluation session in the Virtual Reality scenario, consisting in the percentage difference in the objects activated by the participants with respect to the objects activated by the avatars.
Time 1- at the end the last training session vs Time 0- before starting the first training session
Secondary Outcomes (5)
Change in Non-social Prediction task abilities
Time 1- at the end the last training session vs Time 0- before starting the first training session
Change in Social Cognition
Time 2- up to one month after the end of the intervention vs Time 0- before starting the first training session
Change in Quality of life assessment: TNO-AZL Questionnaires for Children's Health-Related Quality of Life (TACQOL) questionnaire
Time 2- up to one month after the end of the intervention vs Time 0- before starting the first training session
training feasibility assessment: Evaluation of the number of dropouts
Time 1- at the end the last training session
training acceptability assessment: Ad-hoc questionnaire
Time 1- at the end the last training session
Study Arms (2)
Active-tDCS group
EXPERIMENTAL8 sessions (in two weeks) of active tDCS combined with a virtual reality training
Sham-tDCS group
SHAM COMPARATOR8 sessions (in two weeks) of sham tDCS combined with a virtual reality training
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Adolescents and young adults who aged 11-25 years
- Childhood ataxia
- Intelligence Quotient \> 80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
March 5, 2020
Study Start
April 1, 2020
Primary Completion
December 31, 2022
Study Completion
February 15, 2023
Last Updated
March 5, 2020
Record last verified: 2020-03