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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cognitive Dysfunction

Intervention / Treatment
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* Device: multi-channel tDCS
* Device: single-channel tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multi-channel tDCS<br>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). | Device: multi-channel tDCS<br>* multi-channel transcranial direct current stimulation, tDCS<br>|
| Experimental: single-channel tDCS<br>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). | Device: single-channel tDCS<br>* single-channel transcranial direct current stimulation<br>|
| Sham Comparator: sham stimulation<br>The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation. | Device: multi-channel tDCS<br>* multi-channel transcranial direct current stimulation, tDCS<br>Device: single-channel tDCS<br>* single-channel transcranial direct current stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE | Mini-mental State Examination | Change from Baseline MMSE at 2 weeks and 3 months after intervention | 
| MoCA | Montreal Cognitive Assessment | Change from Baseline MoCA at 2 weeks and 3 months after intervention | 
| AVLT | The Auditory-Verbal Learning Test | Change from Baseline AVLT at 2 weeks and 3 months after intervention | 
| WAIS-DST | WAIS Digit Symbol Test | Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEX | Dysexecutive Ques-tionnaire | Change from Baseline DEX at 2 weeks and 3 months after intervention | 
| GNAT | Go/No-go Association Task | Change from Baseline GNAT at 2 weeks and 3 months after intervention |