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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multi-channel tDCS | Experimental | 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). |
|
| single-channel tDCS | Experimental | 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). |
|
| sham stimulation | Sham Comparator | The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-channel tDCS | Device | multi-channel transcranial direct current stimulation, tDCS |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongjie Jiang, Dr. | Contact | +86 13777830137 | insjhj@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongjie Jiang, Dr. | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Ruidong Cheng, Dr. | Zhejiang Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainbowfish Rehabilitation Nursing Care | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| single-channel tDCS | Device | single-channel transcranial direct current stimulation |
|
| Change from Baseline GNAT at 2 weeks and 3 months after intervention |
| Rang Wang, Dr. |
| Rainbowfish Rehabilitation Nursing Care |
| Principal Investigator |
| Jingming Hou, Dr. | Southwest Hospital, China | Principal Investigator |
| SAHZhejiangU | Recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
|
| Southwest Hospital | Recruiting | Chongqing | 400000 | China |
|
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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