A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
NCT ID: NCT04133714
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
180 participants
INTERVENTIONAL
2020-11-01
2023-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 tDCS
multi-channel transcranial direct current stimulation, tDCS
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 tDCS
single-channel transcranial direct current stimulation
sham stimulation
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
multi-channel tDCS
multi-channel transcranial direct current stimulation, tDCS
single-channel tDCS
single-channel transcranial direct current stimulation
Interventions
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multi-channel tDCS
multi-channel transcranial direct current stimulation, tDCS
single-channel tDCS
single-channel transcranial direct current stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Hongjie Jiang, Dr.
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Ruidong Cheng, Dr.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Rang Wang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Rainbowfish Rehabilitation Nursing Care
Jingming Hou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Southwest Hospital, China
Locations
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Rainbowfish Rehabilitation Nursing Care
Hangzhou, Zhejiang, China
SAHZhejiangU
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Southwest Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Ran Wang, Dr.
Role: primary
Hongjie Jiang, Dr.
Role: primary
Ruidong Cheng, Dr.
Role: primary
Jingming Hou, Dr.
Role: primary
Other Identifiers
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2019-313
Identifier Type: -
Identifier Source: org_study_id