Transcranial Static Field Stimulation (tSMS) and Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neurological Symptoms.
NCT ID: NCT06900959
Last Updated: 2025-03-28
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-05-11
2026-02-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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tSMS real and tDCS real
* Real transcranial static magnetic field stimulation (tSMS): will be used to perform the experimental intervention in combination with transcranial Direct Current Stimulation (tDCS), with no interruption between the tSMS and tDCS. Expert personnel will administer 30-minute tSMS stimulations immediately before the tDCS stimulation. tSMS is a non-invasive brain stimulation (NIBS) technique that involves the application of a neodymium magnet to the scalp. Since the first study introducing this method, several others have confirmed that tSMS can lead to a reduction in corticospinal excitability.
* Real transcranial Direct Current Stimulation (tDCS): This device will be used to perform the experimental intervention in combination with tSMS. tDCS stimulations, lasting 20 minutes, will be administered immediately following the tSMS stimulation. tDCS involves the application of weak electrical currents capable of generating an electric field that can modulate neural activity.
transcranial static field stimulation (tSMS) and transcranial (tDCS)
* 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.
tSMS real and tDCS sham
* Real transcranial static magnetic field stimulation (tSMS): will be used to perform the experimental intervention in combination with transcranial Direct Current Stimulation (tDCS), with no interruption between the tSMS and tDCS. Expert personnel will administer 30-minute tSMS stimulations immediately before the tDCS stimulation. tSMS is a non-invasive brain stimulation (NIBS) technique that involves the application of a neodymium magnet to the scalp. Since the first study introducing this method, several others have confirmed that tSMS can lead to a reduction in corticospinal excitability.
* Sham transcranial Direct Current Stimulation (tDCS): in the sham tDCS groups, the duration and electrodes application were the same to real tDCS, but the current was stopped 30 s thereafter. The subject felt the initial itching sensation, but no changes in cortical excitability are producedcapable of generating an electric field that can modulate neural activity.
transcranial static field stimulation (tSMS) and transcranial (tDCS)
* 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.
tSMS sham tDCS real
* Sham transcranial static magnetic field stimulation (tSMS): in the sham tSMS groups, the duration and application of the device were the same as in the real tSMS, but the neodymium magnet is not placed at the location where it should be, and therefore, no actual stimulation occurs.
* Real transcranial direct current stimulation (tDCS): will be administered immediately following the sham tSMS. tDCS stimulations, lasting 20 minutes, will be administered immediately following the tSMS stimulation. tDCS involves the application of weak electrical currents capable of generating an electric field that can modulate neural activity.
transcranial static field stimulation (tSMS) and transcranial (tDCS)
* 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.
tSMS sham tDCS sham
* Sham transcranial static magnetic field stimulation (tSMS): in the sham tSMS groups, the duration and application of the device were the same as in the real tSMS, but the neodymium magnet is not placed at the location where it should be, and therefore, no actual stimulation occurs.
* Sham transcranial Direct Current Stimulation (tDCS): in the sham tDCS groups, the duration and electrodes application were the same to real tDCS, but the current was stopped 30 s thereafter. The subject felt the initial itching sensation, but no changes in cortical excitability are producedcapable of generating an electric field that can modulate neural activity.
transcranial static field stimulation (tSMS) and transcranial (tDCS)
* 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.
Interventions
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transcranial static field stimulation (tSMS) and transcranial (tDCS)
* 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.
Eligibility Criteria
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Inclusion Criteria
* 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;
* Be able to understand and provide written informed consent to the study.
Exclusion Criteria
* 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);
* Concurrent use of medications that may alter synaptic transmission and plasticity (L-dopa, antiepileptics);
* In the case of using NIBS techniques, subjects should not have any contraindications specific to this method (for further details, see the "Methods" and the "Stimulation Assessment Questionnaire" attached to this proposal).
18 Years
80 Years
ALL
No
Sponsors
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Neuromed IRCCS
OTHER
Responsible Party
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Diego Centonze
MD, PhD
Locations
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Istituto Neurologico Mediterraneo IRCCS Neuromed
Pozzilli, Isernia, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIBS-tSMS/tDCS
Identifier Type: -
Identifier Source: org_study_id
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