Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

CAREN: 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 group: 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 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.

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.

Eligibility

Primary outcome measure(s)

• Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG. — 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.

Trial sites (1)

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