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

Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133714
• Other study ID #: 2019-313
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hongjie Jiang, Dr.
• Phone: +86 13777830137
• Email: insjhj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

Device:
• multi-channel tDCS
multi-channel transcranial direct current stimulation, tDCS
• single-channel tDCS
single-channel transcranial direct current stimulation

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing
China	Rainbowfish Rehabilitation Nursing Care	Hangzhou	Zhejiang
China	SAHZhejiangU	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMSE	Mini-mental State Examination	Change from Baseline MMSE at 2 weeks and 3 months after intervention
Primary	MoCA	Montreal Cognitive Assessment	Change from Baseline MoCA at 2 weeks and 3 months after intervention
Primary	AVLT	The Auditory-Verbal Learning Test	Change from Baseline AVLT at 2 weeks and 3 months after intervention
Primary	WAIS-DST	WAIS Digit Symbol Test	Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
Secondary	DEX	Dysexecutive Ques-tionnaire	Change from Baseline DEX at 2 weeks and 3 months after intervention
Secondary	GNAT	Go/No-go Association Task	Change from Baseline GNAT at 2 weeks and 3 months after intervention