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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hongjie Jiang, Dr.
- Telefoonnummer: +86 13777830137
- E-mail: insjhj@zju.edu.cn
Studie Locaties
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Chongqing, China, 400000
- Werving
- Southwest Hospital
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Contact:
- Jingming Hou, Dr.
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Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Werving
- Zhejiang Provincial People's Hospital
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Contact:
- Ruidong Cheng, Dr.
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Hangzhou, Zhejiang, China, 310009
- Werving
- SAHZhejiangU
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Contact:
- Hongjie Jiang, Dr.
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Hangzhou, Zhejiang, China, 310000
- Werving
- Rainbowfish Rehabilitation Nursing Care
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Contact:
- Ran Wang, Dr.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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
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Experimenteel: 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-vergelijker: sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
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multi-channel transcranial direct current stimulation, tDCS
single-channel transcranial direct current stimulation
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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MMSE
Tijdsspanne: Change from Baseline MMSE at 2 weeks and 3 months after intervention
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Mini-mental State Examination
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Change from Baseline MMSE at 2 weeks and 3 months after intervention
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MoCA
Tijdsspanne: Change from Baseline MoCA at 2 weeks and 3 months after intervention
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Montreal Cognitive Assessment
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Change from Baseline MoCA at 2 weeks and 3 months after intervention
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AVLT
Tijdsspanne: Change from Baseline AVLT at 2 weeks and 3 months after intervention
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The Auditory-Verbal Learning Test
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Change from Baseline AVLT at 2 weeks and 3 months after intervention
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WAIS-DST
Tijdsspanne: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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WAIS Digit Symbol Test
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Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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DEX
Tijdsspanne: Change from Baseline DEX at 2 weeks and 3 months after intervention
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Dysexecutive Ques-tionnaire
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Change from Baseline DEX at 2 weeks and 3 months after intervention
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GNAT
Tijdsspanne: 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
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Hongjie Jiang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University
- Hoofdonderzoeker: Ruidong Cheng, Dr., Zhejiang Provincial People's Hospital
- Hoofdonderzoeker: Rang Wang, Dr., Rainbowfish Rehabilitation Nursing Care
- Hoofdonderzoeker: Jingming Hou, Dr., Southwest Hospital, China
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2019-313
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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