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A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke

A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04133714
Enrollment
180
Registered
2019-10-21
Start date
2020-11-01
Completion date
2023-12-31
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Brief summary

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.

Interventions

DEVICEmulti-channel tDCS

multi-channel transcranial direct current stimulation, tDCS

DEVICEsingle-channel tDCS

single-channel transcranial direct current stimulation

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MMSEChange from Baseline MMSE at 2 weeks and 3 months after interventionMini-mental State Examination
MoCAChange from Baseline MoCA at 2 weeks and 3 months after interventionMontreal Cognitive Assessment
AVLTChange from Baseline AVLT at 2 weeks and 3 months after interventionThe Auditory-Verbal Learning Test
WAIS-DSTChange from Baseline WAIS-DST at 2 weeks and 3 months after interventionWAIS Digit Symbol Test

Secondary

MeasureTime frameDescription
DEXChange from Baseline DEX at 2 weeks and 3 months after interventionDysexecutive Ques-tionnaire
GNATChange from Baseline GNAT at 2 weeks and 3 months after interventionGo/No-go Association Task

Countries

China

Contacts

Primary ContactHongjie Jiang, Dr.
insjhj@zju.edu.cn+86 13777830137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026