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

Stroke Clinical Trial

Official title:

The Second Hospital of Dalian Medical University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252987
• Other study ID #: fnirs
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: The Second Affiliated Hospital of Dalian Medical University
• Contact: Wuyao Pan
• Phone: +18186766836
• Email: 331189506[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• routine treatment
Routine medical treatment, basic rehabilitation training and individualized cognitive training
• Non-invasive brain stimulation
tDCS&rTMS

Locations

Country	Name	City	State
China	Lily	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of brain's HbO by functional near-infrared spectroscopy	fNIRS	2 weeks
Secondary	Score of Mini-Mental State Examination	MMSE	2 weeks
Secondary	Score of The Frontal Assessment Battery	FAB	2 weeks
Secondary	Score of Attention assessment by the digit span task	DST	2 weeks