ITMI20110013A1 - SYSTEM AND METHOD FOR THE DETERMINATION OF THRESHOLD INTENSITY FOR DIRECT CURRENT TRANSCRANIAL STIMULATION. - Google Patents
SYSTEM AND METHOD FOR THE DETERMINATION OF THRESHOLD INTENSITY FOR DIRECT CURRENT TRANSCRANIAL STIMULATION. Download PDFInfo
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- ITMI20110013A1 ITMI20110013A1 IT000013A ITMI20110013A ITMI20110013A1 IT MI20110013 A1 ITMI20110013 A1 IT MI20110013A1 IT 000013 A IT000013 A IT 000013A IT MI20110013 A ITMI20110013 A IT MI20110013A IT MI20110013 A1 ITMI20110013 A1 IT MI20110013A1
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- 230000000638 stimulation Effects 0.000 title claims description 26
- 238000000034 method Methods 0.000 title claims description 17
- 210000004556 brain Anatomy 0.000 claims description 16
- 230000000694 effects Effects 0.000 claims description 15
- 230000010287 polarization Effects 0.000 claims description 5
- 238000011282 treatment Methods 0.000 claims description 5
- 230000002490 cerebral effect Effects 0.000 claims description 4
- 238000012545 processing Methods 0.000 claims description 4
- 230000005540 biological transmission Effects 0.000 claims description 2
- 230000001629 suppression Effects 0.000 claims description 2
- 238000001228 spectrum Methods 0.000 description 6
- 238000013459 approach Methods 0.000 description 2
- 230000007177 brain activity Effects 0.000 description 2
- 230000001965 increasing effect Effects 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 210000004761 scalp Anatomy 0.000 description 2
- 238000011491 transcranial magnetic stimulation Methods 0.000 description 2
- 206010001497 Agitation Diseases 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000003321 amplification Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 210000002418 meninge Anatomy 0.000 description 1
- 230000004007 neuromodulation Effects 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 238000003199 nucleic acid amplification method Methods 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 230000003534 oscillatory effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 210000002330 subarachnoid space Anatomy 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000002123 temporal effect Effects 0.000 description 1
- 230000001720 vestibular Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/3603—Control systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- Biophysics (AREA)
- Heart & Thoracic Surgery (AREA)
- Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Description
DESCRIZIONE DESCRIPTION
Annessa a domanda di breveto per INVENZIONE INDUSTRIALE avente per titolo "SISTEMA E METODO PER LA DETERMINAZIONE DELL’INTENSITÀ’ SOGLIA PER LA STIMOLAZIONE TRANSCRANICA A CORRENTE DIRETTA" Attached to a patent application for INDUSTRIAL INVENTION entitled "SYSTEM AND METHOD FOR DETERMINING THE THRESHOLD INTENSITY FOR TRANSCRANICAL DIRECT CURRENT STIMULATION"
La presente invenzione ha per oggetto un sistema per la determinazione dell’intensità soglia per la stimolazione transcranica a corrente continua (tDCS) o polarizzazione cerebrale. Il sistema è costituito da due moduli: uno dedicato alla stimolazione tDCS e alla registrazione di un segnale caratteristico dell’atività eletrica cerebrale; l’altro dedicato al controllo del segnale, all’elaborazione e all’interfaccia con l’operatore. The present invention relates to a system for determining the threshold intensity for direct current transcranial stimulation (tDCS) or cerebral polarization. The system consists of two modules: one dedicated to tDCS stimulation and the recording of a signal characteristic of the brain's electrical activity; the other dedicated to signal control, processing and interface with the operator.
La metodica tDCS o polarizzazione cerebrale consiste nell’erogazione di corrente eletrica continua (DC) atraverso elettrodi posti sullo scalpo ed ha la finalità di indurre modulazioni della funzionalità di aree cerebrali con impiego in ambito sperimentale e con possibili ricadute in ambito clinico (Priori et al. 2003, Nitsche et al. 2008, Utz et al. 2010). The tDCS method or cerebral polarization consists in the supply of continuous electric current (DC) through electrodes placed on the scalp and has the purpose of inducing modulations of the functionality of brain areas with use in the experimental setting and with possible relapses in the clinical setting (Priori et al . 2003, Nitsche et al. 2008, Utz et al. 2010).
Un attuale limite, all’impiego sistematico di tale metodica e all’interpretazione dei risultati degli studi clinici condoti con la medesima, deriva dalla mancanza di variabili che esprimano direttamente o indiretamente la quantità di energia eletrica effetiva che raggiunge il parenchima cerebrale. Infatti, mentre altre metodiche come, per esempio, la TMS (stimolazione magnetica transcranica), inducono movimenti che in relazione all’intensità di stimolazione alla quale essi compaiono esprimono la così detta ‘soglia’, la tDCS non induce movimenti o altri fenomeni obietivabili e quantificabili. Per tale motivo gli studi condoti fino ad oggi hanno sempre impiegato intensità di stimolazione nominale uguali in tuti i soggetti. A current limit to the systematic use of this method and the interpretation of the results of clinical studies conducted with it, derives from the lack of variables that directly or indirectly express the amount of effective electrical energy that reaches the brain parenchyma. In fact, while other methods such as, for example, TMS (transcranial magnetic stimulation), induce movements which, in relation to the intensity of stimulation at which they appear, express the so-called 'threshold', tDCS does not induce movements or other objective phenomena and quantifiable. For this reason, the studies conducted to date have always used the same nominal stimulation intensities in all subjects.
Tuttavia è noto che esiste una notevole variabilità inter-individuale delle proprietà elettriche passive (permittività e conducibilità) legate alla variabilità, per esempio, dello spessore della teca cranica e delle meningi, dell’ampiezza dello spazio sub aracnoideo, delle caratteristiche d’impedenza dei tegumenti, delle proprietà elettrofisiologiche dei neuroni stessi e del loro livello di attività. Rendendo quindi estremamente diversa la quantità di corrente che, a parità di intensità nominale di stimolazione, raggiunge effettivamente il cervello ed è in grado di modulare l’attività cerebrale. However, it is known that there is a considerable inter-individual variability of passive electrical properties (permittivity and conductivity) linked to the variability, for example, of the thickness of the cranial theca and of the meninges, of the width of the sub-arachnoid space, of the impedance characteristics of the integuments, the electrophysiological properties of the neurons themselves and their level of activity. Thus making the amount of current that, with the same nominal stimulation intensity, actually reaches the brain and is able to modulate brain activity, extremely different.
L’attività cerebrale è misurabile con diversi approcci metodologici. Tra questi la rilevazione dell’attività elettrica oscillatoria del cervello (elettroencefalogramma o EEG) costituisce un approccio non invasivo, di basso costo, ad elevata risoluzione temporale e spaziale che è impiegato con successo nei soggetti normali e nei pazienti da quasi un secolo. E’ ormai conoscenza consolidata che l’EEG nel soggetto sano è costituita da diversi ‘ritmi’ a seconda della frequenza; in generale nella pratica clinica si considerano frequenze inferiori ai 30 Hz. L’EEG si deriva per mezzo di elettrodi applicati sulla cute dello scalpo connessi ad un sistema di amplificazione differenziale, il quale, a sua volta, consente sia una visualizzazione "qualitativa” della predetta attività, sia, attraverso diversi algoritmi, un analisi “quantitativa” delle oscillazioni EEG. Tra i parametri quantitativi più frequentemente utilizzati vi sono lo spettro di potenza, le funzioni di bicoerenza e bispettro, mappe etc. Brain activity can be measured with different methodological approaches. Among these, the detection of the oscillatory electrical activity of the brain (electroencephalogram or EEG) is a non-invasive, low-cost, high temporal and spatial resolution approach that has been successfully used in normal subjects and patients for almost a century. It is now well established that the EEG in the healthy subject is made up of different 'rhythms' depending on the frequency; in general, in clinical practice, frequencies below 30 Hz are considered. The EEG is derived by means of electrodes applied to the skin of the scalp connected to a differential amplification system, which, in turn, allows both a "qualitative" visualization of the aforesaid activity, is, through different algorithms, a "quantitative" analysis of the EEG oscillations. Among the most frequently used quantitative parameters are the power spectrum, the bi-coherence and bispectrum functions, maps etc.
Al fine di misurare, in pochi minuti, la quantità di energia della tDCS o polarizzazione cerebrale che raggiunge effettivamente il cervello e che è in grado di interferire con la sua attività, si propone un dispositivo basato sull’impiego combinato della tDCS e della registrazione dell’attività elettrica cerebrale. Esistono alcuni dati infatti che indicano che la tDCS modula l’EEG (Ardolino et al. 2005) anche se non vi sono esperienze di registrazione in linea dell’EEG durante la tDCS ma solo degli effetti indotti dalla medesima dopo lo spegnimento dello stimolatore. In order to measure, in a few minutes, the amount of energy of the tDCS or cerebral polarization that actually reaches the brain and that is able to interfere with its activity, a device based on the combined use of tDCS and recording of the brain is proposed. brain electrical activity. In fact, there are some data that indicate that the tDCS modulates the EEG (Ardolino et al. 2005) even if there are no experiences of online recording of the EEG during the tDCS but only of the effects induced by the same after the stimulator is switched off.
11 brevetto intemazionale WO/2003/066157 (PCT/US2003/0033 16) a nome di Hargrove Jeffrey B. et al. descrive un sistema di neurostimolazione mediante corrente alternata per normalizzare il segnale EEG nelle regioni cerebrali in cui è stata rilevata un’attività irregolare. 11 international patent WO / 2003/066157 (PCT / US2003 / 0033 16) in the name of Hargrove Jeffrey B. et al. describes a neurostimulation system using alternating current to normalize the EEG signal in brain regions where irregular activity was detected.
11 metodo proposto da Hargrove et al. si discosta dalla presente invenzione sia per quanto riguarda l’applicazione, che la modalità d’erogazione del trattamento. Tale metodo propone infatti la modulazione del segnale di neurostimolazione al fine di normalizzare il segnale EEG anziché la stima dell’intensità soglia di stimolazione nel singolo paziente. 11 metodo quindi si basa sulla classica registrazione ed elaborazione del segnale elettroencefalografico (EEG) e sull’erogazione di corrente alternata (AC) per la neuromodulazione anziché correnti continue (DC) come nel caso della tDCS. The method proposed by Hargrove et al. differs from the present invention both as regards the application and the method of providing the treatment. In fact, this method proposes the modulation of the neurostimulation signal in order to normalize the EEG signal instead of estimating the stimulation threshold intensity in the individual patient. The method is therefore based on the classical recording and processing of the electroencephalographic signal (EEG) and on the supply of alternating current (AC) for neuromodulation rather than direct currents (DC) as in the case of tDCS.
Pertanto la prima caratteristica innovativa del presente trovato è la contemporaneità della registrazione elettro-encefalica durante la stimolazione tDCS: tale registrazione avviene attraverso i medesimi elettrodi di stimolazione. Mentre la seconda caratteristica innovativa riguarda l’adattamento inter-individuale dell’intensità di stimolazione. Ulteriori caratteristiche e vantaggi dell’invenzione appariranno maggiormente dalla descrizione dettagliata di una forma di esecuzione preferita, ma non esclusiva, di un sistema per il controllo del processo di identificazione dell’intensità soglia e la somministrazione controllata di trattamenti a correnti elettriche dirette sull’uomo. Tale descrizione verrà effettuata qui di seguito con riferimento agli uniti disegni, fomiti a solo scopo indicativo e pertanto non limitativo, nei quali: Therefore, the first innovative feature of the present invention is the contemporaneity of the electro-brain recording during the tDCS stimulation: this recording takes place through the same stimulation electrodes. While the second innovative feature concerns the inter-individual adaptation of the stimulation intensity. Further characteristics and advantages of the invention will become more apparent from the detailed description of a preferred, but not exclusive, embodiment of a system for the control of the threshold intensity identification process and the controlled administration of direct electric current treatments on humans. . This description will be made hereafter with reference to the accompanying drawings, provided for indicative and therefore non-limiting purposes only, in which:
- la figura 1 mostra lo schema del sistema; - figure 1 shows the scheme of the system;
- la figura 2 mostra l’andamento temporale dell’intensità di stimolazione e gli istanti di registrazione; - Figure 2 shows the time course of the stimulation intensity and the recording instants;
Con riferimento alla figura 1 il sistema è composto da due moduli. Il primo modulo (A) è munito di uno stimolatore a corrente continua (S) e da un sistema di misurazione della differenza di potenziale (R) munito di amplificatore differenziale per segnali bioelettrici. Tale misura corrisponde ad una differenza di potenziale caratteristica del segnale biologico generato in corteccia. Nel sistema sono presenti due differenti utenti: un soggetto che somministra la tDCS (F) ed un soggetto che riceve la tDCS (E). L’apparato di somministrazione (S) applica una corrente elettrica costante al soggetto interessato dal trattamento (F) mentre il rilevatore (R) registra la differenza di potenziale di due elettrodi di stimolazione (G). Il segnale registrato (Vrec) corrisponde alla somma tra la tensione erogata dallo stimolatore (Vstim) e l’attività encefalografica (Veeg). With reference to figure 1, the system is composed of two modules. The first module (A) is equipped with a direct current stimulator (S) and a potential difference measurement system (R) equipped with a differential amplifier for bioelectric signals. This measurement corresponds to a potential difference characteristic of the biological signal generated in the cortex. There are two different users in the system: a subject who administers the tDCS (F) and a subject who receives the tDCS (E). The administration apparatus (S) applies a constant electric current to the subject involved in the treatment (F) while the detector (R) records the potential difference of two stimulation electrodes (G). The recorded signal (Vrec) corresponds to the sum of the voltage delivered by the stimulator (Vstim) and the encephalographic activity (Veeg).
Vrec = Vstim Veeg Vrec = Vstim Veeg
Nota la tensione Vstim, è possibile risalire all’attività Veeg tramite una sottrazione diretta del segnale oppure attraverso una soppressione analogica (utilizzando un filtro passa-alto). Tale segnale viene inviato, nella configurazione preferita, tramite un canale di trasmissione wireless (W), al secondo modulo (B) dove viene elaborato da un microcontrollore (C) e quindi reso visibile all’operatore (F) tramite display (D). Nella configurazione preferita entrambi i moduli A e B sono alimentati a batteria. La corrente di stimolazione viene erogata per un determinato intervallo temporale, ad esempio 1 minuto, al fine di valutare gli effetti della carica iniettata e non effetti postumi o di ‘carry over’. La tensione Vrec viene registrata prima (segnale basale) e durante la stimolazione, come riportato in figura 2. Tale procedura viene ripetuta ciclicamente: ad ogni ciclo l’intensità della corrente viene incrementata. L’intervallo entro cui far variare la corrente di stimolazione e il numero di cicli vengono definiti dall’operatore (F) all’avvio dell’intero processo. La determinazione dell’intensità soglia per il singolo paziente nasce dal confronto dello spettro di potenza del segnale Veeg. Lo spettro di potenza sarà ricavato tramite Γ ausilio di un metodo automatico e attraverso un metodo visuale, supervisionato dall’operatore sanitario (F). In particolare lo spettro verrà suddiviso in tre bande caratteristiche: bassa, media e alta frequenza. In ogni ciclo la varianza dello spettro di potenza del segnale Veeg verrà confrontata con l’equivalente parametro ottenuto dal segnale basale, calcolandone la variazione percentuale (Δ) nelle bande caratteristiche. Terminati tutti i cicli sarà possibile individuare a partire da quale ciclo (ovvero l’intensità soglia di corrente di stimolazione) ed in quale banda caratteristica, si ha una variazione significativa dello spettro di potenza del segnale Veeg. Note the Vstim voltage, it is possible to trace the Veeg activity through a direct subtraction of the signal or through an analog suppression (using a high-pass filter). This signal is sent, in the preferred configuration, via a wireless transmission channel (W), to the second module (B) where it is processed by a microcontroller (C) and then made visible to the operator (F) via the display (D). In the preferred configuration both modules A and B are battery powered. The stimulation current is delivered for a certain time interval, for example 1 minute, in order to evaluate the effects of the injected charge and not after effects or 'carry over'. The Vrec voltage is recorded before (basal signal) and during stimulation, as shown in figure 2. This procedure is repeated cyclically: at each cycle the intensity of the current is increased. The interval within which to vary the stimulation current and the number of cycles are defined by the operator (F) at the start of the entire process. The determination of the threshold intensity for the individual patient arises from the comparison of the power spectrum of the Veeg signal. The power spectrum will be obtained through Γ the aid of an automatic method and through a visual method, supervised by the health worker (F). In particular, the spectrum will be divided into three characteristic bands: low, medium and high frequency. In each cycle, the variance of the power spectrum of the Veeg signal will be compared with the equivalent parameter obtained from the basal signal, calculating the percentage change (Δ) in the characteristic bands. Once all the cycles have been completed, it will be possible to identify starting from which cycle (i.e. the stimulation current threshold intensity) and in which characteristic band, there is a significant variation in the power spectrum of the Veeg signal.
In conclusione il presente trovato permette di determinare un’intensità di stimolo specifica per ogni soggetto, su una base di un indice fisiologico, aumentando pertanto la ripetibilità del trattamento e permettendo lo studio di gruppi di soggetti con livelli d’intensità di stimolo paragonabili per effetto fisiologico. In conclusion, the present invention allows to determine a specific stimulus intensity for each subject, on the basis of a physiological index, thus increasing the repeatability of the treatment and allowing the study of groups of subjects with levels of stimulus intensity comparable in effect. physiological.
BIBLIOGRAFIA BIBLIOGRAPHY
• Priori A. Brain polarization in humans: a reappraisal of an old tool for prolonged noninvasive modulation of brain excitability. Clin Neurophysiol 2003; 114(4):589-595. • Priori A. Brain polarization in humans: a reappraisal of an old tool for prolonged noninvasive modulation of brain excitability. Clin Neurophysiol 2003; 114 (4): 589-595.
• Nitsche M.A., Cohen L.G., Wassermann E.M., Priori A., Lang N., Antal A., Paulus W., Hummel F., Boggio P.S., Fregni F., Pascual-Leone A. Transcranial direct current stimulation: State of thè art 2008. Brain Stimulation 2008; 1 :206-23. • Nitsche M.A., Cohen L.G., Wassermann E.M., Priori A., Lang N., Antal A., Paulus W., Hummel F., Boggio P.S., Fregni F., Pascual-Leone A. Transcranial direct current stimulation: State of theè art 2008. Brain Stimulation 2008; 1: 206-23.
• Utz K.S., Dimova V., OppenlSnder K., Kerkhoff G. Electrified minds: Transcranial direct current stimulation (tDCS) and Galvanic Vestibular Stimulation (GVS) as methods of non-invasive brain stimulation in neuropsychology — A review of current data and future implications. Neuropsychologia 2010;48:2789-2810. • Utz K.S., Dimova V., OppenlSnder K., Kerkhoff G. Electrified minds: Transcranial direct current stimulation (tDCS) and Galvanic Vestibular Stimulation (GVS) as methods of non-invasive brain stimulation in neuropsychology - A review of current data and future implications. Neuropsychologia 2010; 48: 2789-2810.
• Ardolino G., Bossi B., Barbieri S., Priori A. Non-synaptic mechanisms underlie thè aftereffects of cathodal transcutaneous direct current stimulation of thè human brain. J Physiol 2005;568.2:653-663. • Ardolino G., Bossi B., Barbieri S., Priori A. Non-synaptic mechanisms underlie the aftereffects of cathodal transcutaneous direct current stimulation of the human brain. J Physiol 2005; 568.2: 653-663.
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