Transcranial Static Field Stimulation (tSMS) and Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neurological Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: transcranial static field stimulation (tSMS) and transcranial (tDCS) (Combination Product)
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.
干预措施: transcranial static field stimulation (tSMS) and transcranial (tDCS) (Combination Product)
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.
干预措施: transcranial static field stimulation (tSMS) and transcranial (tDCS) (Combination Product)
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.
干预措施: transcranial static field stimulation (tSMS) and transcranial (tDCS) (Combination Product)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from baseline at one week
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.
次要结局
- The Beck Depression Inventory (BDI-II)(Change from baseline at one month)
- State-Trait Anxiety Inventory (STAI)(Change from baseline at one month)
- The Toronto Alexithymia Scale (TAS-20)(Change from baseline at one month)
- 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)
- Zung Self-Rating Depression Scale (SDS)(Change from baseline at one month)
- The Pittsburgh Sleep Quality Index (PSQI)(Change from baseline at one month)
- The Short Form 36 Health Survey (SF-36)(Change from baseline at one month)
- The Fibromyalgia Impact Questionnaire (FIQ)(Change from baseline at one month)
- Modified Fatigue Impact Scale (MFIS)(Change from baseline at one month)
- The Multiple Sclerosis Impact Scale (MSIS-29)(Change from baseline at one month)
- Multiple Sclerosis Quality of Life-54 (MSQOL-54)(Change from baseline at one month)
- Fatigue severity scale (FSS)(Change from baseline at one month)
研究者
Diego Centonze
MD, PhD
Neuromed IRCCS