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Not yet recruiting NCT07573475

The Effect of tDCS Combined With TMS on Cognitive Impairment and Motor Function After Stroke

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 tDCS, sham tDCS, real TMS.
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 →

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Official title

The Effect of Transcranial Electrical Stimulation Combined With Transcranial Magnetic Stimulation on Cognitive Impairment and Motor Function After Stroke

Overview

This clinical trial aims to investigate whether transcranial electrical stimulation (tDCS) combined with transcranial magnetic stimulation(TMS) has an impact on the cognitive and motor functions of stroke patients, and to evaluate the safety of this protocol. The main objective is to answer the following question: Can electromagnetic combined stimulation of the left Dorsolateral prefrontal lobe(DLPFC) improve the performance of working memory, motor function and cognitively motor dual tasks in stroke patients? What is its mechanism of action? Participants will undergo a combined real or sham electromagnetic stimulation of 20 minutes of tDCS and 40 seconds of TMS once a day for 7 days. Researchers will compare the effects of real stimulation with sham stimulation to see if the real stimulation can bring better results to patients. Clinical evaluations (cognitive and motor scales) and functional Near-Infrared Spectroscopy(fNIRS) were conducted before and after stimulation to record relevant brain activities

Interventions

  • Behavioral occupational therapy
    occupational therapy 1 hour a day for 7 days
  • Other real tDCS
    real 20 minutes of tDCS once a day for 7 days
  • Other sham tDCS
    sham 20 minutes of tDCS once a day for 7 days
  • Other real TMS
    40 seconds of real TMS once a day for 7 days
  • Other sham TMS
    40 seconds of sham TMS once a day for 7 days

Primary outcome measures

  • n-back task accuracy rate [Time frame: Baseline and 7-days]
  • n-back task reaction time [Time frame: Baseline and 7-days]
  • functional connectivity during n-back task [Time frame: Baseline and 7-days]
  • Verbal fluency test（VFT）accuracy rate [Time frame: Baseline and 7-days]
  • Verbal fluency test（VFT）reaction time [Time frame: Baseline and 7-days]
  • functional connectivity during Verbal fluency test（VFT） [Time frame: Baseline and 7-days]
Secondary outcome measures (2)
  • Montreal Cognitive Assessment(MoCA) [Time frame: Baseline and 7-days]
  • isokinetic muscle strength test [Time frame: Baseline and 7-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 post-stroke cognitive impairment(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: NCT07573475 · Nos.82302848a

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗