- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04699331
Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
1. februar 2023 opdateret af: Yun-Hee Kim, Samsung Medical Center
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 06351
- Samsung Medical Center
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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
19 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Unilateral stroke patients
- Chronic patients over 6 months after onset
- Patients with motor evoked potential of the first dorsal interosseous muscle
- Patients with the movement of fingers
Exclusion Criteria:
- History of psychiatric disease
- Significant other neurological diseases except for stroke
- Difficult to perform this experiment
- Patients who are deemed difficult to participate in this research by the investigator
- Patients with metal implants and medical devices
- History of epilepsy
- Pregnancy
- Skin defect at the site of electrode attachment
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: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Individualized stimulation group
Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation.
The simulator generates the electrode's location on the scalp.
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Transkraniel jævnstrømsstimulering er en form for ikke-invasiv neuromodulation, der bruger konstant og lav jævnstrøm leveret via elektroder i hovedbunden.
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Aktiv komparator: Conventional stimulation group
Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system.
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Transkraniel jævnstrømsstimulering er en form for ikke-invasiv neuromodulation, der bruger konstant og lav jævnstrøm leveret via elektroder i hovedbunden.
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Sham-komparator: Sham stimulation group
Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system.
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Transkraniel jævnstrømsstimulering er en form for ikke-invasiv neuromodulation, der bruger konstant og lav jævnstrøm leveret via elektroder i hovedbunden.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes in motor evoked potential
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured.
These outcomes are measured by transcranial magnetic stimulation over the motor hotspot.
The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest.
The amplitude means peak to peak of the muscle response.
The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Jebsen-Taylor hand function test
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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9-hole peg test
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Grip & Tip pinch strength test
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Box & Block test
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Fugl-Meyer Assessment
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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The score is a stroke-specific, performance-based impairment index.
The degree of impairment of upper and lower limbs is measured.
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Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
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Sequential motor test
Tidsramme: Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
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Response time and accuracy are measured during finger tapping task.
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Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
29. januar 2021
Primær færdiggørelse (Faktiske)
23. december 2022
Studieafslutning (Faktiske)
23. december 2022
Datoer for studieregistrering
Først indsendt
5. januar 2021
Først indsendt, der opfyldte QC-kriterier
5. januar 2021
Først opslået (Faktiske)
7. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. februar 2023
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. februar 2023
Sidst verificeret
1. februar 2023
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019-07-107
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