The presence of damage to the central and/or peripheral nervous system resulting from various pathologies, such as Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease (PD), Alzheimer's disease (AD), dementia, traumatic brain injury (TBI), stroke, or other neurological syndromes, is commonly a cause of both physical and mental disability. This leads to symptoms in the patient, including: pain, migraines, headaches, neuropathic pain, trigeminal neuralgia, depression, anxiety, apathy, fatigue, cognitive decline, aphasia, functional motor disorders (FMD), neuromuscular tone alterations, and hyposthenia, in addition to involvement of various cognitive functions, such as decision-making, problem-solving, learning, memory, executive functions, social cognition, and emotional cognition. The presence of these neurological symptoms is often evident in a first clinical examination and is one of the main reasons for further healthcare consultations. These difficulties have a profound impact on the quality of life, affecting work, social, and family functioning.
In recent years, several non-invasive brain stimulation (NIBS) techniques have emerged, aimed at eliciting brain neural networks, such as transcranial static magnetic field stimulation (tSMS) and transcranial direct current stimulation (tDCS).
tSMS is an NIBS technique that involves the application of a neodymium magnet on the scalp. Since the first study proposing this method, several others have confirmed that tSMS can reduce corticospinal excitability. tDCS involves the application of weak electrical currents capable of generating an electric field that can modulate neural activity in an excitatory or inhibitory manner. NIBS techniques can be used experimentally to modulate cortical activity.
The primary aim of this proposal is to address the impact of neurological symptoms through the combination of tSMS with tDCS and rehabilitation techniques. Specifically, it aims to understand whether the combination of these neuromodulatory therapeutic NIBS methods can enhance symptom improvement in patients with neurological conditions.
To assess the impact of this intervention, a series of tests and questionnaires, described in detail below, will be used to evaluate the severity of the reported symptoms and secondary outcomes.
Moreover, the contribution of specific brain areas to the symptom will be evaluated through the direct modulation of brain activity. This modulation will be achieved using an additional NIBS technique, such as Transcranial Magnetic Stimulation (TMS). TMS, in particular, is a non-invasive method for stimulating neurons in the brain's superficial areas, which has been frequently used in neurology as a diagnostic and research tool since its introduction. TMS uses magnetic fields to induce electrical currents capable of facilitating or inhibiting cortical activity.
Males or females aged between 18 and 80 years;
Presence of a neurological disorder, specifically the following conditions will be considered: MS, ALS, PD, AD, Dementias, TBI, neurosurgical interventions, stroke, fibromyalgia, epilepsy, headache, migraine, with at least one of the following symptoms: pain, neuropathic pain, neuralgias, depression, anxiety, apathy, fatigue, cognitive decline, aphasia, functional motor disorders (FMD), neuromuscular tone alterations, hyposthenia, involvement of multiple cognitive functions (including decision-making, problem-solving, learning, memory, executive functions, social and emotional cognition);
Patients must be able to follow the protocol instructions for the duration of the study;
Be able to understand the purposes and risks of the study;
Partial or total inability to understand or make decisions, inability to provide written informed consent for the study;
Patients with a history or presence of any unstable medical condition, such as neoplasms or infections;
Women with a positive pregnancy test at baseline or planning to become pregnant. Women who are breastfeeding or have given birth within the last three months prior to the start of the study;
Use of medications that increase the risk of seizures (e.g., Fampridine, 4-aminopyridine);
Parallel
transcranial static field stimulation (tSMS) and transcranial (tDCS)
Combination product* tSMS is a non-invasive brain stimulation (NIBS) technique that involves the application of a neodymium magnet to the scalp. Since the initial study introducing this method, numerous subsequent studies have confirmed that tSMS can lead to a reduction in corticospinal excitability. * Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) technique that applies low-voltage electrical currents through surface electrodes on the scalp. Depending on the stimulation type (anodal or cathodal) tDCS can induce long-lasting increases or decreases in neuronal excitability and vascular-neuronal activity coupling. Cathodal stimulation leads to hyperpolarization and a reduction in excitability, whereas anodal stimulation induces depolarization and enhances excitability.
Visual Analogue Scale (VAS)
The VAS is a self-administered scale in which patients indicate the intensity of pain experienced by selecting a point on a continuous line ranging from 0 to 100 mm, representing the absence of pain to the worst pain, respectively.
Neurological clinical assessment through the Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a clinician-administered assessment scale evaluating the functional systems of the central nervous system. The EDSS is used to describe disease progression in patients with multiple sclerosis MS and to assess the effectiveness of therapeutic interventions in clinical trials. It consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1).
Measurement of motor cortex plasticity through transcranial magnetic stimulation (TMS)
Measurement of motor cortex plasticity (iTBS) through transcranial magnetic stimulation (TMS). The mean amplitudes of motor evoked potentials (MEP) will be recorded following iTBS, at each time point after iTBS (5, 15, and 30 minutes). The LTP-like effect will be expressed as percentage changes relative to the baseline MEPs.
Explore the effects of tSMS+tDCS treatment through the collection of biological material (blood and plasma)
The blood samples, immediately after collection, will undergo the necessary procedures for isolating the different components. These will then be used to analyze the levels of microRNA, cytokines, chemokines, cellular growth factors, markers of neuronal damage (tau, phosphorylated and truncated tau, neurofilaments), mitochondrial markers (lactate), and free d-amino acids. Genotyping studies will be conducted to identify single nucleotide polymorphisms (SNPs) in coding and/or regulatory regions of genes (microRNA or protein) that correlate with specific clinical parameters and the levels of the identified potential biomarkers.
Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a self-administered measure of the sensory and reactive dimensions of pain that is the severity or intensity of the pain and the level of interference it has on various aspects of life. Interference is divided into activity and affective sub-dimensions. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items have not been evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.
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