Ataxia, CerebellarNCT04297540
Neuromodulation of Social Skills in Childhood Ataxia
A study testing Active-tDCS group in people with Ataxia, Cerebellar, run by IRCCS Eugenio Medea.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Ataxia, Cerebellar
- What is being tested?
- Active-tDCS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults who aged 11-25 years
- Childhood ataxia
- Intelligence Quotient > 80
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Cosimo Urgesi contact
About this study
Official title: Neuromodulation Technique for the Rehabilitation of Social Skills in Childhood Ataxia
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.
Read the 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
- Being tested
- Active-tDCS group, Sham-tDCS group
- Keywords
- transcranial direct current stimulation, Childhood ataxia, cerebellum, social skills, virtual reality
- Medical subject headings
- Cerebellar Ataxia, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-tDCS groupDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active-tDCS group | Experimental | 8 sessions (in two weeks) of active tDCS combined with a virtual reality training Receives: Device: Active-tDCS group |
| Sham-tDCS group | Sham comparator | 8 sessions (in two weeks) of sham tDCS combined with a virtual reality training Receives: Device: Sham-tDCS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Performance in the testing phase of the shape prediction task, consisting in the accuracy in discriminating between two alternatives in order to predict the shape of a moving object as a function of different probability of co-occurence between the same shape and a contextual cues, as previously learned during a familiarization phase.
Measured: Time 1- at the end the last training session vs Time 0- before starting the first training session
Change in Social Cognition
Theory of Mind Parts A and B and Emotion Recognition of the NEPSY-II testing battery (Scaled scores ranging 1 to 19, mean=10, standard deviation=3, with higher scores meaning better performance).
Measured: 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
Overall functioning and quality of life assessed using the TNO-AZL Questionnaires for Children's Health-Related Quality of Life (TACQOL), presented in two forms: the self-compiled one and the parent compiled one. The questionnaire comprises 8 different subscales referring to problems/limitations in general physical functioning (Body subscale);.in motor functioning (Motor subscales); in independent daily functioning (Auto subscale); in cognitive functioning and school performance (cognit subscale); in social contacts with parents and peers (Social scale); to the occurrence of positive moods (Empos subscale) or negative moods (Emoneg scale). The sum scores may range from 0 to 32 for Body, Motor, Cognit, Auto and Social scales. For Empos and Emoneg the scores vary between 0 and 16.
The calculated scale scores are all in the same direction: a low score indicates a lower Health-Related Quality of Life (HRQoL); a high score indicates a higher HRQoL.
Measured: 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
Evaluation of the number of dropouts: number of patient who renounce to complete the whole training Evaluation of the number of sessions completed per patient: total number of sessions performed in front of the total number proposed of eight sessions
Measured: Time 1- at the end the last training session
training acceptability assessment: Ad-hoc questionnaire
Ad-hoc questionnaire completed by participants and by their parents to assess subjective evaluation of training accessibility and efficacy (10 cm Visual Analogue scales with higher values corresponding to greater agreement).
Measured: Time 1- at the end the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startApr 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia, CerebellarStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297540
- Sponsor's protocol ID
- 742
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Technique for the Rehabilitation of Social Skills in Childhood Ataxia
- ClinicalTrials.gov ID
- NCT04297540
- Acronym / sponsor ID
- 742
- Conditions
- Ataxia, Cerebellar
- Keywords
- transcranial direct current stimulation, Childhood ataxia, cerebellum, social skills, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-tDCS group | Experimental | Device: Active-tDCS group8 sessions (in two weeks) of active tDCS combined with a virtual reality training |
| Sham-tDCS group | Sham comparator | Device: Sham-tDCS group8 sessions (in two weeks) of sham tDCS combined with a virtual reality training |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents and young adults who aged 11-25 years
- Childhood ataxia
- Intelligence Quotient > 80
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active-tDCS groupActive 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 | Active-tDCS group |
| Sham-tDCS groupSham -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. | Device | Sham-tDCS group |
Primary outcome
Change in Social Prediction abilities in the Action Prediction task
Time frame: Time 1- at the end the last training session vs Time 0- before starting the first training session
-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.
Change in Social Prediction abilities in the Virtual Reality scenario
Time frame: Time 1- at the end the last training session vs Time 0- before starting the first training session
-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.
5 secondary outcomes
Change in Non-social Prediction task abilities
Time frame: Time 1- at the end the last training session vs Time 0- before starting the first training session
Change in Social Cognition
Time frame: 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 frame: 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 frame: Time 1- at the end the last training session
training acceptability assessment: Ad-hoc questionnaire
Time frame: Time 1- at the end the last training session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cosimo Urgesi contact
Questions about this trial
What is this clinical trial studying?
A study testing Active-tDCS group in people with Ataxia, Cerebellar, run by IRCCS Eugenio Medea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Finisguerra (+390432693111, alessandra.finisguerra@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Prediction abilities in the Action Prediction task (time frame: Time 1- at the end the last training session vs Time 0- before starting the first training session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.