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

NCT04133714 | Unknown

• 1 other identifier: 2019-313
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• DEX

  Change from Baseline DEX at 2 weeks and 3 months after intervention

• GNAT

  Change from Baseline GNAT at 2 weeks and 3 months after intervention

Study Arms (3)

multi-channel tDCS

EXPERIMENTAL

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

single-channel tDCS

EXPERIMENTAL

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

sham stimulation

SHAM COMPARATOR

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

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

Interventions

multi-channel tDCS DEVICE

multi-channel transcranial direct current stimulation, tDCS

multi-channel tDCS; sham stimulation

single-channel tDCS DEVICE

single-channel transcranial direct current stimulation

sham stimulation; single-channel tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (4)

Rainbowfish Rehabilitation Nursing Care

Hangzhou, Zhejiang, 310000, China

RECRUITING

SAHZhejiangU

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Southwest Hospital

Chongqing, 400000, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hongjie Jiang, Dr.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongjie Jiang, Dr.

CONTACT

+86 13777830137; insjhj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 21, 2019
• Study Start: November 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 29, 2020

Record last verified: 2019-10

Locations

CN (4)