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

Last updated: October 27, 2020
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Memory Loss

Treatment

N/A

Clinical Study ID

NCT04133714
2019-313
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 180
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Rainbowfish Rehabilitation Nursing Care

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • SAHZhejiangU

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

  • Southwest Hospital

    Chongqing, 400000
    China

    Active - Recruiting

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