- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07593859
Overcoming the Barriers to Effective Transcranial Temporal Interference Stimulation in Humans
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Remedies for treatment resistance in psychiatric and neurological disorders is a great unmet need. Invasive neuromodulation, such as deep brain stimulation (DBS), applied to a targeted brain region is one option that has helped regulate or modify, abnormal electrical patterns in many patients with neurological deficits; However, invasive approaches carry significant risks while having limited targeting flexibility. Transcranial temporal interference stimulation (TIS) is a non-invasive neuromodulation method with much more favorable focus in deep brain targets than traditional forms of transcranial alternating current stimulation (tACS). tTIS achieves its focal effect by delivering two sinusoidal currents, that are both high in frequency, but that are slightly different from one another (e.g. 1000 kHz and 1020 kHz) through electrodes placed on the scalp. Frequencies that are in the kilohertz range alone do not elicit neuronal response, however the interaction of the two high-frequency currents creates an electric field with a high-frequency carrier (fc, e.g. 1010 kHZ) that is modulated by a low-frequency beat (fb, e.g. 20 Hz). If fc is high enough (>1 kHz) and fb low enough (<100 Hz), neurons respond much more strongly to fb than fc.
Safety and tolerability of TIS has recently been demonstrated in humans with findings indicating that TIS poses no greater risk than other common non-invasive techniques for transcranial current stimulation (TCS). The spatial distribution of the beat field (Eb) is distinct from other noninvasive stimulation methods in three ways: 1) it is focal, 2) it can peak deep in the brain, 3) it can be steered through the brain without moving the electrodes. These features have been demonstrated in mouse experiments, and in human simulation studies.
In humans, motor-evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) applied to the motor cortex provide an established assay of corticospinal excitability. TMS experiments have provided direct evidence that phase-dependent neuromodulation can be induced by transcranial alternating current stimulation (tACS), a form of transcranial current stimulation that is similar to temporal interference stimulation (TIS) but lacks focality and steerability, yet has been key to understanding its neurophysiological effects in humans. For example, recent experimental results showed that TMS pulses time locked to tACS over motor cortex induced MEP amplitude modulation that was dependent on the phase of the tACS oscillatory currents. Building on this finding, the investigators will provide TMS pulses to motor cortex during tTIS and investigate whether neuromodulation of corticospinal excitability depends on the phase of beat frequency (fb). Similar to the experiments that showed neural activation in mice, the investigators will also investigate whether the strength of the effect depends on the carrier frequency (fc). The investigators will use computationally optimized electrode placement, with high- and low-frequency controls, to test that effects are unambiguously due to fb. Finally, the investigators will assess corticospinal excitability PRE and POST stimulation to investigate neuroplasticity induced by TIS. The knowledge gained in this experiment will demonstrate the extent to which modulation effects of TIS in humans are due entrainment of neural activity at fb. This information will provide a basis for the future use of tTIS for clinical applications.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Joanne Hall, M.Sc.
- Telefonní číslo: 17027828483
- E-mail: hall.joa@northeastern.edu
Studijní místa
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02115-5724
- Nábor
- Northeastern University
-
Kontakt:
- Mathew Yarossi, PhD
- Telefonní číslo: 7027828483
- E-mail: m.yarossi@northeastern.edu
-
Vrchní vyšetřovatel:
- Mathew Yarossi, PhD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Free of neurological or orthopedic conditions that may impact the ability to participate.
- Right-hand dominant (self-reported)
- Aged 18-65 years
Exclusion Criteria:
- Ferromagnetic metal implants in the brain/skull or elsewhere (dental implants excluded).
- Any implanted electronic device (e.g. cardiac pacemaker, cochlear implant, deep brain stimulator, medication infusion pump; vagal nerve stimulator)
- Diseased or damaged skin on face or scalp
- History of migraines, fainting, seizures/epilepsy, or psychiatric illness
- Neurological disorder or intracranial lesion
- Frequent or severe headaches
- Prior adverse reaction to transcranial magnetic stimulation
- Currently pregnant
- Suspected or diagnosed heart problems (e.g. arrhythmia, cardiac disturbances).
- Insulin-dependent diabetes
- Suspected or diagnosed epilepsy or a familial history of epilepsy
- Use of alcohol or recreational drugs in the prior 12 hours
- Use of prescription and over the counter medications will be grounds for exclusion except for: contraceptive (birth control) drugs (e.g. those containing ethinyl estradiol and/or norethindrone), and seasonal allergy medications (e.g. cetirizine (Zyrtec), fexofenadine (Allegra), and loratadine (Claritin)).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 990-1010 Hz fb
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
Experimentální: 1990-2010 Hz fb
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
Experimentální: 1000-1000 Hz fb
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
Experimentální: 2000-2000 Hz fb
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
Experimentální: 20 Hz
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
|
Falešný srovnávač: sham
|
We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex).
Motor evoked potentials will be recorded using electromyography (EMG).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Online phase-dependent modulation of corticospinal excitability using the relevance value (R.V.)
Časové okno: Periprocedural
|
Explained variance (R2) of best-fit sinusoids will be multiplied by the variance of measured values to obtain the established "relevance value" (R.V.), to be used as our primary outcome.
Relevance values assume phase-dependent modulation with a large amplitude is more meaningful than one with small amplitude and the same R2.
Critically, phase-dependent responses to TIS represent direct evidence of modulation at beat frequency (fb).
|
Periprocedural
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Offline neuroplastic effects from pre to post
Časové okno: Periprocedural
|
We define neuro- plastic effects as sustained modulation of excitability fol- lowing cessation of transcranial current sitmulation (tCS).
Fifteen single-pulse MEPs will be acquired at the FDI hotspot prior to and at 0, 15 and 30 minutes after tCS (tpre, t0, t15, t30).
Our primary outcome will be MEP amplitude change from tpre to t0.
|
Periprocedural
|
|
Offline neuroplastic post effects
Časové okno: Periprocedural
|
Retention of neuromodulation at t15 and t30.
|
Periprocedural
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Mathew Yarossi, PhD, Northeastern University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 25-02-54
- 5R01NS133229 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .