NCT06252987

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 12, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 17, 2024

Last Update Submit

February 1, 2024

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Concentration of brain's HbO by functional near-infrared spectroscopy

    fNIRS

    2 weeks

Secondary Outcomes (3)

  • Score of Mini-Mental State Examination

    2 weeks

  • Score of The Frontal Assessment Battery

    2 weeks

  • Score of Attention assessment by the digit span task

    2 weeks

Study Arms (4)

common group

SHAM COMPARATOR

routine training

Other: routine treatment

tDCS group

EXPERIMENTAL

tDCS

Other: routine treatmentOther: Non-invasive brain stimulation

rTMS group

EXPERIMENTAL

rTMS

Other: routine treatmentOther: Non-invasive brain stimulation

Combination group

EXPERIMENTAL

tDCS-rTMS

Other: routine treatmentOther: Non-invasive brain stimulation

Interventions

routine treatmentOTHER

Routine medical treatment, basic rehabilitation training and individualized cognitive training

Combination groupcommon grouprTMS grouptDCS group
Non-invasive brain stimulationOTHER

tDCS\&rTMS

Combination grouprTMS grouptDCS group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lily

Dalian, Liaoning, 116021, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yongmei Jiang

    Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University

    STUDY DIRECTOR

Central Study Contacts

Wuyao Pan

CONTACT

+18186766836331189506@qq.com

Ren

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 12, 2024

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)