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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

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ClinicalTrials.gov Identifier: NCT04133714
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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.


Condition or disease Intervention/treatment Phase
Cognitive Dysfunction Device: multi-channel tDCS Device: single-channel tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center RCT Study on the Efficacy and Mechanism of Multi-channel tDCS in Rehabilitation of Cognitive Function After Stroke
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. MMSE [ Time Frame: Change from Baseline MMSE at 2 weeks and 3 months after intervention ]
    Mini-mental State Examination

  2. MoCA [ Time Frame: Change from Baseline MoCA at 2 weeks and 3 months after intervention ]
    Montreal Cognitive Assessment

  3. AVLT [ Time Frame: Change from Baseline AVLT at 2 weeks and 3 months after intervention ]
    The Auditory-Verbal Learning Test

  4. WAIS-DST [ Time Frame: Change from Baseline WAIS-DST at 2 weeks and 3 months after intervention ]
    WAIS Digit Symbol Test


Secondary Outcome Measures :
  1. DEX [ Time Frame: Change from Baseline DEX at 2 weeks and 3 months after intervention ]
    Dysexecutive Ques-tionnaire

  2. GNAT [ Time Frame: Change from Baseline GNAT at 2 weeks and 3 months after intervention ]
    Go/No-go Association Task



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04133714     History of Changes
Other Study ID Numbers: 2019-XXX
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders