Transcranial Static Field Stimulation (tSMS) and Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neurological Symptoms.

NCT06900959 | Not Yet Recruiting

• 1 other identifier: NIBS-tSMS/tDCS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurological Diseases or Conditions

Keywords

neuromodulation; non-invasive brain stimulation; transcranial direct current stimulation tDCS; transcranial static field stimulation tSMS

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at one week

Secondary Outcomes (16)

• Neurological clinical assessment through the Expanded Disability Status Scale (EDSS)

  Change from baseline at one month

• Measurement of motor cortex plasticity through transcranial magnetic stimulation (TMS)

  Change from baseline at one month

• Explore the effects of tSMS+tDCS treatment through the collection of biological material (blood and plasma)

  Change from baseline at one month

• Brief Pain Inventory (BPI)

  Change from baseline at one month

• Zung Self-Rating Anxiety Scale (SAS)

  Change from baseline at one month

Study Arms (4)

tSMS real and tDCS real

EXPERIMENTAL

* 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.

Combination Product: transcranial static field stimulation (tSMS) and transcranial (tDCS)

tSMS real and tDCS sham

ACTIVE COMPARATOR

* 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.

Combination Product: transcranial static field stimulation (tSMS) and transcranial (tDCS)

tSMS sham tDCS real

ACTIVE COMPARATOR

* 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.

Combination Product: transcranial static field stimulation (tSMS) and transcranial (tDCS)

tSMS sham tDCS sham

SHAM COMPARATOR

* 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.

Combination Product: transcranial static field stimulation (tSMS) and transcranial (tDCS)

Interventions

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.

tSMS real and tDCS real; tSMS real and tDCS sham; tSMS sham tDCS real; tSMS sham tDCS sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Be able to understand and provide written informed consent to the study.

You may not qualify if:

• 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);
• 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).

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Istituto Neurologico Mediterraneo IRCCS Neuromed

Pozzilli, Isernia, 86077, Italy

Location

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MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Diego Centonze, MD, PhD

CONTACT

0865929170; centonze@uniroma2.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 28, 2025
• Study Start: May 11, 2025
• Primary Completion: December 11, 2025
• Study Completion: February 11, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)