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
• Interventions: Device: multi-channel tDCS; Device: single-channel tDCS

• 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

Arm && Interventions

Group	Intervention	Description
multi-channel tDCS	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).
sham stimulation	single-channel tDCS	The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
single-channel 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).
sham stimulation	multi-channel tDCS	The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.

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)

Southwest Hospital; 🇨🇳 Chongqing, China

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

SAHZhejiangU; 🇨🇳 Hangzhou, Zhejiang, China

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