Det midlertidigt forstyrrende hos patienter med bevidsthedsforstyrrelser
20. juli 2026 opdateret af: Li Zhang, MD, Zhejiang Provincial People's Hospital
Effektiviteten og sikkerheden ved midlertidigt at blande sig hos patienter med bevidsthedsforstyrrelser
Dette projekt vil hjælpe patienten med at gendanne bevidstheden ved at give TI (midlertidigt forstyrrende) behandling
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310000
- Hangzhou Mingzhou Brain Rehabilitation Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inkluderingskriterier:
I overensstemmelse med de internationale diagnostiske kriterier for MC'er formuleret af Giacino i 2002 eller de diagnostiske kriterier for UWS foreslået af Laureys i 2010; Patienter med sygdomsvarighed ≥28 dage og ubevidst forbedringstendens i den sidste måned; Ingen brug af beroligende lægemidler eller antiepileptiske lægemidler (natrium- eller calciumkanalblokkere) i den sidste 1 måned; stabile vitale tegn; Intet åbenlyst hjerneødem, hydrocephalus og alvorlig hjerneatrofi; Alder fra 18 til 70 år gammel; Informeret samtykke blev opnået fra patienternes familiemedlemmer.
Ekskluderingskriterier:
Tidligere historie med neurologiske eller psykiatriske lidelser; Tidligere historie med traumatisk hjerneskade; Kræfthistorie; At tage beroligende stoffer eller antiepileptiske stoffer i den sidste 1 måned; Ustabile vitale tegn; Kraniumdefekt; Patientenes familiemedlemmer underskrev ikke det informerede samtykke.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Sham-komparator: Sham comparator
Participants receive sham TI stimulation one session per day for 5 consecutive days
|
The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
|
|
Aktiv komparator: real TI stimulation
Participants receive real TI stimulation one session per day for 5 consecutive days
|
Stimulation was delivered as two sinusoidal alternating currents with carrier frequencies of 2000 Hz and 2010 Hz, generating a 10 Hz amplitude-modulated envelope.
Current intensity was set at 3 mA per channel.
Each session included 30-second ramp-up and ramp-down periods at the beginning and end of stimulation.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
CRS-R (Coma Recovery Scale-revised)
Tidsramme: Baseline; Within 1 week post-stimulation
|
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
|
Baseline; Within 1 week post-stimulation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
EEG spectral power
Tidsramme: Baseline; Within 1 week post-stimulation
|
EEG spectral power was quantified across five canonical frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
Relative power spectral density (PSD) was calculated for each frequency band.
|
Baseline; Within 1 week post-stimulation
|
|
fNIRS-derived hemoglobin concentration changes
Tidsramme: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
|
Changes in oxygenated hemoglobin (ΔHbO), deoxygenated hemoglobin (ΔHbR), and total hemoglobin (ΔHbT) concentrations were measured using functional near-infrared spectroscopy (fNIRS).
|
fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
|
|
GOS-E（Glasgow Outcome Scale - Extended）
Tidsramme: 6 months
|
The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.
|
6 months
|
|
Changes in CRS-R subscale scores
Tidsramme: Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
|
Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
|
Total CRS-R score changes at follow-up
Tidsramme: Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness.
The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness.
The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
|
Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
|
|
EEG functional connectivity
Tidsramme: Baseline; Within 1 week post-stimulation
|
EEG functional connectivity was quantified using phase-locking value (PLV) across five frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
|
Baseline; Within 1 week post-stimulation
|
|
Auditory steady-state response (ASSR)
Tidsramme: Baseline; Within 1 week post-stimulation
|
ASSR was recorded during EEG while participants listened to modulated tones.
ASSR strength was quantified using an amplitude-based signal-to-noise ratio (SNR), calculated as the amplitude at the target frequency divided by the mean amplitude of the surrounding spectral background.
|
Baseline; Within 1 week post-stimulation
|
|
fNIRS-derived functional connectivity
Tidsramme: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
|
Functional connectivity was estimated by calculating Pearson correlation coefficients between fNIRS time series.
|
fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023.
- Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. januar 2025
Primær færdiggørelse (Faktiske)
31. oktober 2025
Studieafslutning (Faktiske)
30. april 2026
Datoer for studieregistrering
Først indsendt
16. januar 2025
Først indsendt, der opfyldte QC-kriterier
6. februar 2025
Først opslået (Faktiske)
12. februar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TI-DOC
Plan for individuelle deltagerdata (IPD)
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