Menu
Not yet recruiting NCT07573501

Dual-site Cross-frequency Coupled Transcranial Electrical Stimulation Modulates Working Memory of Patients With Post-stroke Cognitive Impairment

No phase Interventional Stroke Cognition Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: occupational therapy, real tACS, sham tACS.
Who it may be relevant to
Registry conditions: Stroke, Cognition Disorders. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This clinical trial aims to explore the effect of dual-site theta-gamma cross-frequency coupled transcranial alternating current stimulation in the frontal and parietal region on the working memory ability of patients with cognitive impairment after stroke, and to evaluate the safety of this protocol. The main purpose is to answer the following question: Can dual-site cross-frequency coupled tACS in the frontal parietal region improve the performance of working memory and cognitive-motor dual tasks in stroke patients? What is its mechanism of action? Researchers will compare the effects of real cross-frequency coupled stimuli and sham stimuli to see if the real stimuli can bring better results to patients. Participants will receive 40 minutes of real or sham electrical stimulation once a day for 5 consecutive days. Clinical evaluations (cognitive scales) and fNIRS were conducted respectively before and after stimulation to record the relevant brain activities at rest and during cognitive tasks

Interventions

  • Behavioral occupational therapy
    occupational therapy (especially cognitive therapy) 40min a day for 5 days
  • Other real tACS
    real theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy
  • Other sham tACS
    sham theta-gamma CFC tACS for 40min a day for 5 days during cognitive therapy

Primary outcome measures

  • n-back task accuracy rate [Time frame: Baseline and 5-days]
  • n-back task reaction time [Time frame: Baseline and 5-days]
  • function connectivity during n-back task [Time frame: Baseline and 5-days]
  • Verbal fluency test（VFT）accuracy rate [Time frame: Baseline and 5-days]
  • Verbal fluency test（VFT）reaction time [Time frame: Baseline and 5-days]
  • function connectivity during Verbal fluency test（VFT） [Time frame: Baseline and 5-days]
Secondary outcome measures (1)
  • Montreal Cognitive Assessment(MoCA) [Time frame: Baseline and 5-days]

Eligibility criteria

Inclusion criteria

  • Meeting the diagnostic criteria for hemorrhagic or ischemic stroke in the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases(2nd edition), with the first onset, single hemisphere stroke, and confirmed by CT or MRI,course of diease 1-6 months;
  • Age ranging from 30 to 80 years old;
  • Native language is Mandarin or Cantonese;
  • Right-handed;
  • Diagnosed with PSCI by the MoCA scale;
  • Able to cooperate in completing the speech repetition test;
  • Normal hearing.

Exclusion criteria

  • Currently receiving non-invasive brain stimulation treatment;
  • Lesions involving the left DLPFC brain regions;
  • History of epilepsy, mental illness,or other neurological or mental disorders;
  • Any contraindications for transcranial electrical stimulation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen Universi — Guangzhou

Identifiers

NCT: NCT07573501 · Nos.82302848b

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗