Healthy Individuals (Controls)Allena-menteNCT07066137
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
A study testing CAREN in people with Healthy Individuals (Controls) and Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals (Controls), Parkinson Disease, Multiple Sclerosis
- What is being tested?
- CAREN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20.
Who cannot join
- Severe medical and psychiatric disorders potentially affecting the training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Me, 98123
Rocco Salvatore Calabrò, PhD, +3909061128133, roccos.calabro@irccsme.it
Maria Grazia Maggio, PhD
About this study
Official title: Motor Planning, Execution, and Modulation in Healthy Individuals and Patients With Movement Disorders or Neuromuscular Diseases Using Traditional Physical Activity or Advanced Devices to Enhance Motor Learning and Sensorimotor Processing
The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases.
This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy.
Read more
The main questions it aims to answer are:
How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery.
Participants will:
- Undergo various rehabilitation protocols including physical activity and advanced interventions.
- Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.
Read the detailed description
Objectives
Primary Objectives Investigating Motor Gesture Control: Study the sensory-motor structures and their connectivity in healthy participants and patients with neurological, cardiovascular, or neuromuscular conditions. This includes analyzing responses to advanced interventions such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and the CAREN (Computer Assisted Rehabilitation Environment) system.
Understanding Central Control Mechanisms: Assess spatial and temporal changes in brain activity during motor training and recovery processes, leveraging advanced neuroimaging techniques (e.g., fMRI, dtMRI, NIRS).
Secondary Objectives Postural Disorder Prevention: Develop strategies to enhance postural stability and prevent related disorders, improving sports performance and the quality of life in patients with neurodegenerative conditions.
Integration of Imaging and Psychometric Data: Employ multimodal data to uncover brain function patterns and inform rehabilitation strategies, contributing to personalized recovery protocols and optimized training methods.
Methodology Study Design
This is an interventional study aimed at evaluating the metabolic, functional, and neurophysiological aspects of motor responses in participants subjected to intensive physical and cognitive training. By combining traditional therapies with innovative technologies (e.g., CAREN, IVS3, AlterG, tDCS, TMS), the study will explore:
Central nervous system activation and connectivity. Temporal and spatial dynamics of motor learning and maintenance. The role of proprioceptive, visual, and auditory inputs in motor coordination.
Phases of Study Phase 1: Recruitment and Baseline Assessments Participants will be recruited through direct communication and provided with detailed study information.
Baseline evaluations will include:
Clinical and medical-sports assessment. Neuropsychological evaluation (e.g., MoCA, TMT, Stroop Test). Postural and gait analysis. Baseline imaging (MRI, EEG). Phase 2: Intervention and Data Collection
Participants will undergo structured interventions:
Physiotherapy sessions combined with neuromodulation techniques. Training on the CAREN system to assess and improve motor and postural functions.
Use of advanced devices for electromyographic data collection, oxygen consumption measurements, and 3D gait analysis.
Imaging and functional assessments will be repeated post-intervention.
Phase 3: Data Analysis and Dissemination Collected data will be anonymized, processed using advanced imaging and statistical algorithms, and analyzed for correlations between training responses and functional recovery.
Results will be published in high-impact international journals. Technologies and Assessments
Neuroimaging Techniques:
Functional and structural MRI (including T1-weighted, T2-weighted, and DTI sequences).
Analysis of mean diffusivity and fractional anisotropy to evaluate white matter integrity.
NIRS to assess cortical hemodynamics during tasks.
Neurophysiological Tools:
EEG and ECG to monitor the electrical activity of the brain and heart. Surface electromyography (EMG) to evaluate muscle activation patterns.
Advanced Rehabilitation Devices:
CAREN system: A virtual environment platform for motor and postural rehabilitation.
Alter-G/Gait Trainer 3 for assisted gait training. IVS3 FLIR system for thermal imaging of muscular activity.
Neuropsychological Assessments:
Comprehensive cognitive evaluation, including MoCA, TMT, Stroop, and PASAT. Auditory anamnesis and visuomotor training (e.g., S.V.T.A.).
Population The study aims to recruit 150 participants, including healthy individuals and patients aged 18-70 years with neurological conditions (stroke, dementia, Parkinson's Disease, Multiple Sclerosis, Spinal Cord Injury). Detailed inclusion and exclusion criteria ensure the selection of suitable candidates.
Ethical and Administrative Aspects All participants will provide informed consent per ethical guidelines (Declaration of Helsinki and GDPR compliance).
The relevant Ethics Committee approves the study, with no additional costs or compensations.
Results will be transparently reported, adhering to international research standards.
- Conditions
- Healthy Individuals (Controls), Parkinson Disease, Multiple Sclerosis, Alzheimer Disease, Dementia, Stroke
- Being tested
- CAREN, Control group
- Keywords
- Virtual Reality, motor rehabilitation, cognitive rehabilitation, Functional Recovery
- Medical subject headings
- Parkinson Disease, Multiple Sclerosis, Alzheimer Disease, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARENDevice
The interventions include proprioceptive stimuli combined with specific rehabilitation protocols, such as Tabata training, plyometric training, and visual-cognitive-motor enhancement with the S.V.T.A. method.
Healthy subjects and athletes (about 50) will participate in intensive aerobic and anaerobic training, including sensory-motor-cognitive training and exercises on the CAREN platform. Another 25 participants will have TMS/tDCS and music therapy added to their regimen.
Regarding neurological patients, 50 participants will undergo posture and gait rehabilitation using the CAREN platform, while 25 will receive non-invasive neuromodulation to enhance their rehabilitation outcomes. This arm of the study focuses on the recovery of motor and cognitive functions.
This study uses the CAREN system as a tool for physical rehabilitation in neurological and healthy participants. The device is not being investigated for new indications and the study is conducted entirely in Italy.
Control groupOther
the control group is typically the group that does not receive the experimental treatment or intervention, serving as a baseline to compare the effects of the intervention. However, in the context you're describing with healthy subjects and athletes, here's how it's structured:
Healthy subjects and athletes (around 50 participants) will undergo:
Intensive aerobic and anaerobic training Sensory-motor-cognitive training
Additionally, 25 of these participants will receive:
Transcranial Magnetic Stimulation (TMS) Transcranial Direct Current Stimulation (tDCS) Music therapy This approach allows for a comparison between the effects of the physical and cognitive training alone versus the enhanced effects when combined with neuromodulation (TMS, tDCS) and music therapy. This design will help in assessing the added value of these interventions on performance
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | The subjects will undergo baseline examinations including MRI, spirometry, surface electromyography, 3D gait analysis, postural assessment and stabilometric analysis, O2 consumption measurement, neuropsychological assessment, ECG, and EEG.
Subsequently, the healthy subjects (approximately 50) will undergo intensive aerobic and anaerobic training (including sensory-motor-cognitive training) and exercises on the CAREN platform. For the other 25 participants, transcranial magnetic stimulation (TMS)/transcranial direct current stimulation (tDCS) and music therapy will be added. Receives: Other: Control group |
| Experimental group | Experimental | As for the neurological patients (50), they will undergo posture and gait rehabilitation using the CAREN platform, while the other 25 will receive additional enhancement through non-invasive neuromodulation. This constitutes the other arm of the study. Receives: Device: CAREN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG.
Motor-related EEG activity will be recorded during the execution of standardized gestures. The primary outcome is the mean amplitude (in µV) of specific ERP components (e.g., N200, P300) over motor cortex electrodes. Data will be averaged across trials for each participant and reported as group means ± standard deviation. Differences between healthy participants and clinical groups will be assessed using appropriate statistical tests.
Measured: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Secondary outcomes (2)
Respiratory Exchange Ratio (RER) During Submaximal Exercis
Metabolic efficiency will be assessed through the respiratory exchange ratio (RER = VCO₂/VO₂) during submaximal steady-state exercise. RER will be measured at standardized workload levels and summarized as mean ± SD. Comparisons between groups or timepoints will assess changes in substrate utilization patterns.
Measured: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Change in Global Cognitive Function as Measured by MoCA Total Score
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The primary outcome is the change in total score (range: 0-30) from baseline to post-intervention. Data will be summarized as mean ± SD and analyzed using paired or independent statistical tests, depending on the study design.
Measured: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start5 May 2024
- Primary completion6 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Individuals (Controls)Studies of the same condition, open and under way.
- 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
- Model description
- Type of Study: Interventional Objective: To evaluate the effects of advanced physiotherapy techniques and neuromodulation on motor and cognitive functions in both healthy individuals and patients with neurological conditions. Interventions: Physiotherapy, Cryotherapy, ultrasound therapy, laser therapy, music therapy, Neuromodulation: TMS, tDCS. Innovative technology (e.g. Virtual Reality -CAREN, IVS3 , AlterG) Proprioceptive stimulation and motor rehab, Intensive aerobic and anaerobic training. Groups: 1. Healthy Participants 2. Patients Phases: Recruitment: Initial evaluations and baseline data collection. Intervention: Application of treatments and regular assessments. Follow-up: Post-intervention evaluations and data analysis. Duration: Approximately 5 years. Outcome Measures: Improvements in motor performance, cognitive functions, and quality of life.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rocco Salvatore Calabrò, PhD, Study director, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066137
- Sponsor's protocol ID
- Allena-mente
- Acronym
- Allena-mente
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we plan to share individual participant data (IPD) with other researchers. The data will be made available through a secure platform, ensuring participant confidentiality and compliance with ethical guidelines. Access will be granted under a data use agreement that requires anonymization and outlines permitted uses. We encourage collaborative research and publication of findings derived from the shared data for a period of five years following the study's completion.
Publications
Bonanno M, De Pasquale P, De Marchis C, Lombardo Facciale A, Paladina G, Fonti B, Quartarone A, Calabro RS. Might patients with cerebellar ataxia benefit from the Computer Assisted Rehabilitation ENvironment (CAREN)? A pilot study focusing on gait and balance. Front Bioeng Biotechnol. 2024 Jun 24;12:1385280. doi: 10.3389/fbioe.2024.1385280. eCollection 2024.
PubMed 39011156De Pasquale P, Bonanno M, Lombardo Facciale A, Maggio MG, Thaut MH, Hurt C, Quartarone A, Impellizzeri F, Calabro RS. Can neurologic music therapy make the difference when using immersive virtual reality in Parkinson disease motor training? Promising findings from a secondary analysis. Front Rehabil Sci. 2026 Feb 26;7:1707528. doi: 10.3389/fresc.2026.1707528. eCollection 2026.
PubMed 41835097
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Planning, Execution, and Modulation in Healthy Individuals and Patients With Movement Disorders or Neuromuscular Diseases Using Traditional Physical Activity or Advanced Devices to Enhance Motor Learning and Sensorimotor Processing
- ClinicalTrials.gov ID
- NCT07066137
- Acronym / sponsor ID
- Allena-mente / Allena-mente
- Conditions
- Healthy Individuals (Controls), Parkinson Disease, Multiple Sclerosis, Alzheimer Disease, Dementia, Stroke
- Keywords
- Virtual Reality, motor rehabilitation, cognitive rehabilitation, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 6 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jul 2025 (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 goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases.
This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy.
The main questions it aims to answer are:
How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery.
Participants will:
- Undergo various rehabilitation protocols including physical activity and advanced interventions.
- Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.
Detailed description
Objectives
Primary Objectives Investigating Motor Gesture Control: Study the sensory-motor structures and their connectivity in healthy participants and patients with neurological, cardiovascular, or neuromuscular conditions. This includes analyzing responses to advanced interventions such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and the CAREN (Computer Assisted Rehabilitation Environment) system.
Understanding Central Control Mechanisms: Assess spatial and temporal changes in brain activity during motor training and recovery processes, leveraging advanced neuroimaging techniques (e.g., fMRI, dtMRI, NIRS).
Secondary Objectives Postural Disorder Prevention: Develop strategies to enhance postural stability and prevent related disorders, improving sports performance and the quality of life in patients with neurodegenerative conditions.
Integration of Imaging and Psychometric Data: Employ multimodal data to uncover brain function patterns and inform rehabilitation strategies, contributing to personalized recovery protocols and optimized training methods.
Methodology Study Design
This is an interventional study aimed at evaluating the metabolic, functional, and neurophysiological aspects of motor responses in participants subjected to intensive physical and cognitive training. By combining traditional therapies with innovative technologies (e.g., CAREN, IVS3, AlterG, tDCS, TMS), the study will explore:
Central nervous system activation and connectivity. Temporal and spatial dynamics of motor learning and maintenance. The role of proprioceptive, visual, and auditory inputs in motor coordination.
Phases of Study Phase 1: Recruitment and Baseline Assessments Participants will be recruited through direct communication and provided with detailed study information.
Baseline evaluations will include:
Clinical and medical-sports assessment. Neuropsychological evaluation (e.g., MoCA, TMT, Stroop Test). Postural and gait analysis. Baseline imaging (MRI, EEG). Phase 2: Intervention and Data Collection
Participants will undergo structured interventions:
Physiotherapy sessions combined with neuromodulation techniques. Training on the CAREN system to assess and improve motor and postural functions.
Use of advanced devices for electromyographic data collection, oxygen consumption measurements, and 3D gait analysis.
Imaging and functional assessments will be repeated post-intervention.
Phase 3: Data Analysis and Dissemination Collected data will be anonymized, processed using advanced imaging and statistical algorithms, and analyzed for correlations between training responses and functional recovery.
Results will be published in high-impact international journals. Technologies and Assessments
Neuroimaging Techniques:
Functional and structural MRI (including T1-weighted, T2-weighted, and DTI sequences).
Analysis of mean diffusivity and fractional anisotropy to evaluate white matter integrity.
NIRS to assess cortical hemodynamics during tasks.
Neurophysiological Tools:
EEG and ECG to monitor the electrical activity of the brain and heart. Surface electromyography (EMG) to evaluate muscle activation patterns.
Advanced Rehabilitation Devices:
CAREN system: A virtual environment platform for motor and postural rehabilitation.
Alter-G/Gait Trainer 3 for assisted gait training. IVS3 FLIR system for thermal imaging of muscular activity.
Neuropsychological Assessments:
Comprehensive cognitive evaluation, including MoCA, TMT, Stroop, and PASAT. Auditory anamnesis and visuomotor training (e.g., S.V.T.A.).
Population The study aims to recruit 150 participants, including healthy individuals and patients aged 18-70 years with neurological conditions (stroke, dementia, Parkinson's Disease, Multiple Sclerosis, Spinal Cord Injury). Detailed inclusion and exclusion criteria ensure the selection of suitable candidates.
Ethical and Administrative Aspects All participants will provide informed consent per ethical guidelines (Declaration of Helsinki and GDPR compliance).
The relevant Ethics Committee approves the study, with no additional costs or compensations.
Results will be transparently reported, adhering to international research standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Type of Study: Interventional Objective: To evaluate the effects of advanced physiotherapy techniques and neuromodulation on motor and cognitive functions in both healthy individuals and patients with neurological conditions. Interventions: Physiotherapy, Cryotherapy, ultrasound therapy, laser therapy, music therapy, Neuromodulation: TMS, tDCS. Innovative technology (e.g. Virtual Reality -CAREN, IVS3 , AlterG) Proprioceptive stimulation and motor rehab, Intensive aerobic and anaerobic training. Groups: 1. Healthy Participants 2. Patients Phases: Recruitment: Initial evaluations and baseline data collection. Intervention: Application of treatments and regular assessments. Follow-up: Post-intervention evaluations and data analysis. Duration: Approximately 5 years. Outcome Measures: Improvements in motor performance, cognitive functions, and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Other: Control groupThe subjects will undergo baseline examinations including MRI, spirometry, surface electromyography, 3D gait analysis, postural assessment and stabilometric analysis, O2 consumption measurement, neuropsychological assessment, ECG, and EEG. Subsequently, the healthy subjects (approximately 50) will undergo intensive aerobic and anaerobic training (including sensory-motor-cognitive training) and exercises on the CAREN platform. For the other 25 participants, transcranial magnetic stimulation (TMS)/transcranial direct current stimulation (tDCS) and music therapy will be added. |
| Experimental group | Experimental | Device: CARENAs for the neurological patients (50), they will undergo posture and gait rehabilitation using the CAREN platform, while the other 25 will receive additional enhancement through non-invasive neuromodulation. This constitutes the other arm of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20.
Key exclusion criteria (1 listed)
- Severe medical and psychiatric disorders potentially affecting the training
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 |
|---|---|---|
| CARENThe interventions include proprioceptive stimuli combined with specific rehabilitation protocols, such as Tabata training, plyometric training, and visual-cognitive-motor enhancement with the S.V.T.A. method. Healthy subjects and athletes (about 50) will participate in intensive aerobic and anaerobic training, including sensory-motor-cognitive training and exercises on the CAREN platform. Another 25 participants will have TMS/tDCS and music therapy added to their regimen. Regarding neurological patients, 50 participants will undergo posture and gait rehabilitation using the CAREN platform, while 25 will receive non-invasive neuromodulation to enhance their rehabilitation outcomes. This arm of the study focuses on the recovery of motor and cognitive functions. This study uses the CAREN system as a tool for physical rehabilitation in neurological and healthy participants. The device is not being investigated for new indications and the study is conducted entirely in Italy. | Device | Experimental group |
| Control groupthe control group is typically the group that does not receive the experimental treatment or intervention, serving as a baseline to compare the effects of the intervention. However, in the context you're describing with healthy subjects and athletes, here's how it's structured: Healthy subjects and athletes (around 50 participants) will undergo: Intensive aerobic and anaerobic training Sensory-motor-cognitive training Additionally, 25 of these participants will receive: Transcranial Magnetic Stimulation (TMS) Transcranial Direct Current Stimulation (tDCS) Music therapy This approach allows for a comparison between the effects of the physical and cognitive training alone versus the enhanced effects when combined with neuromodulation (TMS, tDCS) and music therapy. This design will help in assessing the added value of these interventions on performance | Other | Healthy Subjects |
Primary outcome
Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG.
Time frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Motor-related EEG activity will be recorded during the execution of standardized gestures. The primary outcome is the mean amplitude (in µV) of specific ERP components (e.g., N200, P300) over motor cortex electrodes. Data will be averaged across trials for each participant and reported as group means ± standard deviation. Differences between healthy participants and clinical groups will be assessed using appropriate statistical tests.
2 secondary outcomes
Respiratory Exchange Ratio (RER) During Submaximal Exercis
Time frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Change in Global Cognitive Function as Measured by MoCA Total Score
Time frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 39011156Bonanno M, De Pasquale P, De Marchis C, Lombardo Facciale A, Paladina G, Fonti B, Quartarone A, Calabro RS. Might patients with cerebellar ataxia benefit from the Computer Assisted Rehabilitation ENvironment (CAREN)? A pilot study focusing on gait and balance. Front Bioeng Biotechnol. 2024 Jun 24;12:1385280. doi: 10.3389/fbioe.2024.1385280. eCollection 2024.
- Derived from this study: PubMed 41835097De Pasquale P, Bonanno M, Lombardo Facciale A, Maggio MG, Thaut MH, Hurt C, Quartarone A, Impellizzeri F, Calabro RS. Can neurologic music therapy make the difference when using immersive virtual reality in Parkinson disease motor training? Promising findings from a secondary analysis. Front Rehabil Sci. 2026 Feb 26;7:1707528. doi: 10.3389/fresc.2026.1707528. eCollection 2026.
- Individual participant dataSharing planned: Yes. we plan to share individual participant data (IPD) with other researchers. The data will be made available through a secure platform, ensuring participant confidentiality and compliance with ethical guidelines. Access will be granted under a data use agreement that requires anonymization and outlines permitted uses. We encourage collaborative research and publication of findings derived from the shared data for a period of five years following the study's completion.
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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.
Rocco Salvatore Calabrò, PhD study director
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREN in people with Healthy Individuals (Controls) and Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Grazia Maggio, Phd (+3909061128250, mariagrazia.maggio@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG. (time frame: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066137, which also lists 2 linked publications.
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 3 Nov 2026.