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

Not Applicable

• Conditions: Cognitive Dysfunction

• Registration Number: NCT04133714
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2020-11-01
• Primary Completion: 2023-03
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
GNAT	Change from Baseline GNAT at 2 weeks and 3 months after intervention	Go/No-go Association Task
DEX	Change from Baseline DEX at 2 weeks and 3 months after intervention	Dysexecutive Ques-tionnaire

Trial Locations

Locations (4)

Rainbowfish Rehabilitation Nursing Care; 🇨🇳 Hangzhou, Zhejiang, China

SAHZhejiangU; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Southwest Hospital; 🇨🇳 Chongqing, China