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

Официальное название

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

Обзор

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.

Вмешательства

• Комбинированный продукт 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

Первичные конечные точки

• Visual Analogue Scale (VAS) [Срок оценки: Change from baseline at one week]

Вторичные конечные точки (12)

• Neurological clinical assessment through the Expanded Disability Status Scale (EDSS) [Срок оценки: Change from baseline at one month]
• Measurement of motor cortex plasticity through transcranial magnetic stimulation (TMS) [Срок оценки: Change from baseline at one month]
• Explore the effects of tSMS+tDCS treatment through the collection of biological material (blood and plasma) [Срок оценки: Change from baseline at one month]
• Brief Pain Inventory (BPI) [Срок оценки: Change from baseline at one month]
• Zung Self-Rating Anxiety Scale (SAS) [Срок оценки: Change from baseline at one month]
• Zung Self-Rating Depression Scale (SDS) [Срок оценки: Change from baseline at one month]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Change from baseline at one month]
• The Short Form 36 Health Survey (SF-36) [Срок оценки: Change from baseline at one month]
• The Beck Depression Inventory (BDI-II) [Срок оценки: Change from baseline at one month]
• State-Trait Anxiety Inventory (STAI) [Срок оценки: Change from baseline at one month]
• The Toronto Alexithymia Scale (TAS-20) [Срок оценки: Change from baseline at one month]
• The Fibromyalgia Impact Questionnaire (FIQ) [Срок оценки: Change from baseline at one month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Istituto Neurologico Mediterraneo IRCCS Neuromed — Pozzilli

Публикации

• Zitser J, Allen IE, Falgas N, Le MM, Neylan TC, Kramer JH, Walsh CM. Pittsburgh Sleep Quality Index (PSQI) responses are modulated by total sleep time and wake after sleep onset in healthy older adults. PLoS One. 2022 Jun 24;17(6):e0270095. doi: 10.1371/journal.pone.0270095. eCollection 2022. PMID 35749529
• Zhang R, Lam CLM, Peng X, Zhang D, Zhang C, Huang R, Lee TMC. Efficacy and acceptability of transcranial direct current stimulation for treating depression: A meta-analysis of randomized controlled trials. Neurosci Biobehav Rev. 2021 Jul;126:481-490. doi: 10.1016/j.neubiorev.2021.03.026. Epub 2021 Mar 28. PMID 33789158
• Zettin M, Bondesan C, Nada G, Varini M, Dimitri D. Transcranial Direct-Current Stimulation and Behavioral Training, a Promising Tool for a Tailor-Made Post-stroke Aphasia Rehabilitation: A Review. Front Hum Neurosci. 2021 Dec 20;15:742136. doi: 10.3389/fnhum.2021.742136. eCollection 2021. PMID 34987366
• Wilson MA, Greenwell D, Meek AW, Poston B, Riley ZA. Neuroenhancement of a dexterous motor task with anodal tDCS. Brain Res. 2022 Sep 1;1790:147993. doi: 10.1016/j.brainres.2022.147993. Epub 2022 Jun 26. PMID 35760153
• Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23. PMID 24402217
• Verhoog MB, Goriounova NA, Obermayer J, Stroeder J, Hjorth JJ, Testa-Silva G, Baayen JC, de Kock CP, Meredith RM, Mansvelder HD. Mechanisms underlying the rules for associative plasticity at adult human neocortical synapses. J Neurosci. 2013 Oct 23;33(43):17197-208. doi: 10.1523/JNEUROSCI.3158-13.2013. PMID 24155324
• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. PMID 24505342
• Vanbellingen T, Nyffeler T, Nigg J, Janssens J, Hoppe J, Nef T, Muri RM, van Wegen EEH, Kwakkel G, Bohlhalter S. Home based training for dexterity in Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2017 Aug;41:92-98. doi: 10.1016/j.parkreldis.2017.05.021. Epub 2017 May 25. PMID 28578819

Идентификаторы

NCT: NCT06900959 · NIBS-tSMS/tDCS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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