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

Primary Purpose

Cognitive Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multi-channel tDCS
single-channel tDCS
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rainbowfish Rehabilitation Nursing CareRecruiting
  • SAHZhejiangURecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

multi-channel tDCS

single-channel tDCS

sham stimulation

Arm Description

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).

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).

The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.

Outcomes

Primary Outcome Measures

MMSE
Mini-mental State Examination
MoCA
Montreal Cognitive Assessment
AVLT
The Auditory-Verbal Learning Test
WAIS-DST
WAIS Digit Symbol Test

Secondary Outcome Measures

DEX
Dysexecutive Ques-tionnaire
GNAT
Go/No-go Association Task

Full Information

First Posted
October 14, 2019
Last Updated
October 27, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04133714
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multi-channel tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
single-channel tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
The shame stimulation group had only 30 seconds of up and down stimulation, with no intermediate stimulation.
Intervention Type
Device
Intervention Name(s)
multi-channel tDCS
Intervention Description
multi-channel transcranial direct current stimulation, tDCS
Intervention Type
Device
Intervention Name(s)
single-channel tDCS
Intervention Description
single-channel transcranial direct current stimulation
Primary Outcome Measure Information:
Title
MMSE
Description
Mini-mental State Examination
Time Frame
Change from Baseline MMSE at 2 weeks and 3 months after intervention
Title
MoCA
Description
Montreal Cognitive Assessment
Time Frame
Change from Baseline MoCA at 2 weeks and 3 months after intervention
Title
AVLT
Description
The Auditory-Verbal Learning Test
Time Frame
Change from Baseline AVLT at 2 weeks and 3 months after intervention
Title
WAIS-DST
Description
WAIS Digit Symbol Test
Time Frame
Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention
Secondary Outcome Measure Information:
Title
DEX
Description
Dysexecutive Ques-tionnaire
Time Frame
Change from Baseline DEX at 2 weeks and 3 months after intervention
Title
GNAT
Description
Go/No-go Association Task
Time Frame
Change from Baseline GNAT at 2 weeks and 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjie Jiang, Dr.
Phone
+86 13777830137
Email
insjhj@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongjie Jiang, Dr.
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ruidong Cheng, Dr.
Organizational Affiliation
Zhejiang Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rang Wang, Dr.
Organizational Affiliation
Rainbowfish Rehabilitation Nursing Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jingming Hou, Dr.
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rainbowfish Rehabilitation Nursing Care
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Wang, Dr.
Facility Name
SAHZhejiangU
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjie Jiang, Dr.
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruidong Cheng, Dr.
Facility Name
Southwest Hospital
City
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingming Hou, Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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