A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
This clinical RCT study intends to combined different forms of multi-channel tDCS with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction.
The therapeutic effects among single-channel tDCS group, multi-channel tDCS and pseudo-multichannel tDCS group will be compared. Brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tDCS technology for PSCI brain network.
Thus, the efficacy and mechanism of multi-channel tDCS in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hongjie Jiang, Dr.
- Telefonnummer: +86 13777830137
- E-post: insjhj@zju.edu.cn
Studiesteder
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Chongqing, Kina, 400000
- Rekruttering
- Southwest Hospital
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Ta kontakt med:
- Jingming Hou, Dr.
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310014
- Rekruttering
- Zhejiang Provincial People's Hospital
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Ta kontakt med:
- Ruidong Cheng, Dr.
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Hangzhou, Zhejiang, Kina, 310009
- Rekruttering
- SAHZhejiangU
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Ta kontakt med:
- Hongjie Jiang, Dr.
-
Hangzhou, Zhejiang, Kina, 310000
- Rekruttering
- Rainbowfish Rehabilitation Nursing Care
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Ta kontakt med:
- Ran Wang, Dr.
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18-60 year-old
- diagnosed cerebral apoplexy, meeting the diagnostic criteria of ICD-10
- cognitive function, perceptual function decline after stroke
- first onset and duration of 3-12 months
- right-handed
- MMSE ≤25
- MoCA ≤25
- sign informed consent voluntarily and comply with the study plan
Exclusion Criteria:
- NIHSS ≥21 points
- MoCA ≤18, or DRS-2 ≤ 124, or CES-D ≥ 16
- taking drugs that affect central nervous activity, such as nerve antagonists
- specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas
- patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect MRI examination
- patients with a previous history of epilepsy, mental illness or skull injury
- patients with dementia or obvious cognitive dysfunction before stroke
- patients with aphasia or dysarthria and cannot complete the scale evaluation
- pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: multi-channel tDCS
In the multi-channel tDCS stimulation group, a 1:4 (anode: cathode) approach was applied, with the central anode placed in the left dorsolateral prefrontal cortex (dlPFC) (reference 10-20 standard lead EEG), and the remaining cathode distributed around the central electrode. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
multi-channel transcranial direct current stimulation, tDCS
|
|
Eksperimentell: single-channel tDCS
The anode electrode of the single-channel tDCS stimulation group was placed in the left dlPFC, and the cathode electrode was placed in the right orbital forehead. The rising time and falling time of current are 30 seconds respectively. Stimulate 30 minutes daily for 10 days (Monday to Friday, once a day, weekend off). |
single-channel transcranial direct current stimulation
|
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Sham-komparator: sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
|
multi-channel transcranial direct current stimulation, tDCS
single-channel transcranial direct current stimulation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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MMSE
Tidsramme: Change from Baseline MMSE at 2 weeks and 3 months after intervention
|
Mini-mental State Examination
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Change from Baseline MMSE at 2 weeks and 3 months after intervention
|
|
MoCA
Tidsramme: Change from Baseline MoCA at 2 weeks and 3 months after intervention
|
Montreal Cognitive Assessment
|
Change from Baseline MoCA at 2 weeks and 3 months after intervention
|
|
AVLT
Tidsramme: Change from Baseline AVLT at 2 weeks and 3 months after intervention
|
The Auditory-Verbal Learning Test
|
Change from Baseline AVLT at 2 weeks and 3 months after intervention
|
|
WAIS-DST
Tidsramme: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
|
WAIS Digit Symbol Test
|
Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
DEX
Tidsramme: Change from Baseline DEX at 2 weeks and 3 months after intervention
|
Dysexecutive Ques-tionnaire
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Change from Baseline DEX at 2 weeks and 3 months after intervention
|
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GNAT
Tidsramme: Change from Baseline GNAT at 2 weeks and 3 months after intervention
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Go/No-go Association Task
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Change from Baseline GNAT at 2 weeks and 3 months after intervention
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Hongjie Jiang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University
- Hovedetterforsker: Ruidong Cheng, Dr., Zhejiang Provincial People's Hospital
- Hovedetterforsker: Rang Wang, Dr., Rainbowfish Rehabilitation Nursing Care
- Hovedetterforsker: Jingming Hou, Dr., Southwest Hospital, China
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019-313
Legemiddel- og utstyrsinformasjon, studiedokumenter
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