Clinical trial NCT04133714: A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
Official title: A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: MMSE
timeFrame: Change from Baseline MMSE at 2 weeks and 3 months after intervention
measure: MoCA
timeFrame: Change from Baseline MoCA at 2 weeks and 3 months after intervention
measure: AVLT
timeFrame: Change from Baseline AVLT at 2 weeks and 3 months after intervention
measure: WAIS-DST
timeFrame: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
Secondary outcomes:
measure: DEX
timeFrame: Change from Baseline DEX at 2 weeks and 3 months after intervention
measure: GNAT
timeFrame: Change from Baseline GNAT at 2 weeks and 3 months after intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Rainbowfish Rehabilitation Nursing Care
state: Zhejiang
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Hongjie Jiang, Dr.
role: STUDY_CHAIR
affiliation: Zhejiang Provincial People's Hospital
name: Ruidong Cheng, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rainbowfish Rehabilitation Nursing Care
name: Rang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Hospital, China
name: Jingming Hou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: