StrokeNCT06252987
The Effects of tDCS Combined With rTMS on Post-stroke Cognitive Impairment
A study testing routine treatment and Non-invasive brain stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- routine treatment and Non-invasive brain stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ren contact
China1 site, 1 recruiting
- Recruiting
Lily
Dalian, Liaoning, 116021
Wuyao Pan, +18186766836
About this study
Official title: The Second Hospital of Dalian Medical University
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.
- Conditions
- Stroke
- Being tested
- routine treatment, Non-invasive brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine treatmentOther
Routine medical treatment, basic rehabilitation training and individualized cognitive training
Non-invasive brain stimulationOther
tDCS\&rTMS
| Study group | Role | What they receive |
|---|---|---|
| common group | Sham comparator | routine training Receives: Other: routine treatment |
| tDCS group | Experimental | tDCS Receives: Other: routine treatment; Other: Non-invasive brain stimulation |
| rTMS group | Experimental | rTMS Receives: Other: routine treatment; Other: Non-invasive brain stimulation |
| Combination group | Experimental | tDCS-rTMS Receives: Other: routine treatment; Other: Non-invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of brain's HbO by functional near-infrared spectroscopy
fNIRS
Measured: 2 weeks
Secondary outcomes (3)
Score of Mini-Mental State Examination
MMSE
Measured: 2 weeks
Score of The Frontal Assessment Battery
FAB
Measured: 2 weeks
Score of Attention assessment by the digit span task
DST
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Nov 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongmei Jiang, Study director, Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252987
- Sponsor's protocol ID
- fnirs
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Hospital of Dalian Medical University
- ClinicalTrials.gov ID
- NCT06252987
- Acronym / sponsor ID
- fnirs
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| common group | Sham comparator | Other: routine treatmentroutine training |
| tDCS group | Experimental | Other: routine treatment, Other: Non-invasive brain stimulationtDCS |
| rTMS group | Experimental | Other: routine treatment, Other: Non-invasive brain stimulationrTMS |
| Combination group | Experimental | Other: routine treatment, Other: Non-invasive brain stimulationtDCS-rTMS |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine treatmentRoutine medical treatment, basic rehabilitation training and individualized cognitive training | Other | Combination group, common group, rTMS group, tDCS group |
| Non-invasive brain stimulationtDCS\&rTMS | Other | Combination group, rTMS group, tDCS group |
Primary outcome
Concentration of brain's HbO by functional near-infrared spectroscopy
Time frame: 2 weeks
fNIRS
3 secondary outcomes
Score of Mini-Mental State Examination
Time frame: 2 weeks
Score of The Frontal Assessment Battery
Time frame: 2 weeks
Score of Attention assessment by the digit span task
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ren contact
Yongmei Jiang study director
Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine treatment and Non-invasive brain stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wuyao Pan (+18186766836, 331189506@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of brain's HbO by functional near-infrared spectroscopy (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.