The Effects of tDCS Combined With rTMS on Post-stroke Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: routine treatment; Other: Non-invasive brain stimulation

• Registration Number: NCT06252987
• Lead Sponsor: The Second Affiliated Hospital of Dalian Medical University

Brief Summary

If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]

The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]

* \[Explore brain network features with functional near-infrared spectroscopy\] Participants will receive conventional treatment, tDCS treatment, or rTMS treatment, or tDCS-rTMS treatment.

And then compare cognitive function and brain function.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
• 30-80 years old, right-handed, unilateral hemiplegia;
• Verbal expression can cooperate with the completion of the evaluation, sustained attention time is longer than 5 minutes;
• Simple Mental State Examination Scale (MMSE) score ≤26 points; MoCA scale score < 26 points; Memory test (RMBT) score less than 21 points;
• patients or their family agree to sign the informed consent;
• The Ethics Committee approved the trial.

Exclusion Criteria

• Memory dysfunction caused by other diseases, such as Alzheimer's disease, lewy body dementia, pituitary tumor surgery, hypothyroidism, etc.;
• There are contraindications of rTMS and tDCS for untreated intracranial aneurysms, severe epilepsy, intracranial metal, etc.
• Patients with severe visual, cognitive or speech impairment who cannot cooperate with treatment;
• The condition is not stable; Or other serious physical diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS group	Non-invasive brain stimulation	tDCS
rTMS group	routine treatment	rTMS
rTMS group	Non-invasive brain stimulation	rTMS
common group	routine treatment	routine training
Combination group	Non-invasive brain stimulation	tDCS-rTMS
tDCS group	routine treatment	tDCS
Combination group	routine treatment	tDCS-rTMS

Primary Outcome Measures

Name	Time	Method
Concentration of brain's HbO by functional near-infrared spectroscopy	2 weeks	fNIRS

Secondary Outcome Measures

Name	Time	Method
Score of Mini-Mental State Examination	2 weeks	MMSE
Score of The Frontal Assessment Battery	2 weeks	FAB
Score of Attention assessment by the digit span task	2 weeks	DST

Trial Locations

Locations (1)

Lily; 🇨🇳 Dalian, Liaoning, China