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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction
• Intervention / Treatment: Device: multi-channel tDCS; Device: single-channel tDCS

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongjie Jiang, Dr.; Phone Number: +86 13777830137; Email: insjhj@zju.edu.cn

Study Locations

• China
  • Chongqing, China, 400000
    • Recruiting
    • Southwest Hospital
    • Contact: Jingming Hou, Dr.
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Ruidong Cheng, Dr.
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • SAHZhejiangU
      • Contact: Hongjie Jiang, Dr.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Rainbowfish Rehabilitation Nursing Care
      • Contact: Ran Wang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: multi-channel tDCS; multi-channel transcranial direct current stimulation, tDCS
Experimental: 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).	Device: single-channel tDCS; single-channel transcranial direct current stimulation
Sham Comparator: sham stimulation; The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.	Device: multi-channel tDCS; multi-channel transcranial direct current stimulation, tDCS; Device: single-channel tDCS; single-channel transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Hongjie Jiang, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University; Principal Investigator: Ruidong Cheng, Dr., Zhejiang Provincial People's Hospital; Principal Investigator: Rang Wang, Dr., Rainbowfish Rehabilitation Nursing Care; Principal Investigator: Jingming Hou, Dr., Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2019-313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No