StrokeNCT06386614
Effect of Frontal Transcranial Direct Current Stimulation on BDNF in Stroke Patients With Cognitive Impairment
A study testing Routine treatment and Transcranial Direct Current Stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian Medical University at 2 sites in China.
Trial summary
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 the relationship between BDNF level and cognitive function] Participants will receive… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Routine treatment and Transcranial Direct Current Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 1 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Stroke patients with CT or MRI imaging evidence, among which ischemic stroke met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and cerebral hemorrhage diseases met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Cerebral hemorrhage 2019; (2) There are symptoms related to cognitive dysfunction; Cognitive dysfunction was assessed by rehabilitation physicians. According to the MoCA evaluation standard,MoCA score ≤26 points; according to the MMSE evaluation standard, illiteracy score ≤17 points; primary school education level ≤20 points; secondary school education (including secondary school) level ≤22 points; college education (including junior college) level ≤23 points; (3)Age range 40-80 years old; (4) no obvious aphasia, speech expression and attention can cooperate with the completion of evaluation and treatment; (5)The patient or the patient's family members read and agree to sign the informed consent.
Who cannot join
- (1) Patients with severe diseases, such as malignant arrhythmia, acute myocardial infarction and acute heart failure, who cannot tolerate rehabilitation treatment; (2) Patients with untreated intracranial aneurysms, severe epilepsy, and intracranial metals who cannot receive tDCS treatment; (3) Non-PSCI patients with cognitive impairment, including patients with cognitive impairment left over from previous stroke and other organ disorders.
Trial locations and contacts
2 sites in 1 country.
Ren contact
China2 sites, 1 recruiting
- Completed
Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University
Dalian, Liaoning, 116021
- Recruiting
Lily
Dalian, Liaoning, 116021
Yang Tu, 18875214238, 715700399@qq.com
About this study
Official title: The Second Hospital of Dalian Medical University
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 the relationship between BDNF level and cognitive function] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level
Read the detailed description
- To study the therapeutic effect of transcranial direct current stimulation (tDCS) on post-stroke cognitive impairment (PSCI) by evaluating cognitive function and detecting plasma brain-derived neurotrophic factor (BDNF).
- To explore the correlation between plasma BDNF level and cognitive function in patients with PSCI.
- Conditions
- Stroke
- Being tested
- Routine treatment, Transcranial Direct Current 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
Also called Routine medical treatment, basic rehabilitation training, individualized cognitive training
Both groups were given routine treatment
Transcranial Direct Current StimulationOther
The common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation
| Study group | Role | What they receive |
|---|---|---|
| common group routine training | Sham comparator | Conventional rehabilitation Receives: Other: Routine treatment |
| tDCS group | Experimental | Conventional rehabilitation plus TDCS treatment Receives: Other: Routine treatment; Other: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF
Plasma BDNF was determined by elisa
Measured: 2 weeks
Secondary outcomes (3)
Cognitive function level
Score of Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment(MoCA)
Measured: 2 weeks
Executive function level
core of The Frontal Assessment Battery（FAB）
Measured: 2 weeks
Memory function level
Score of Rivermead Behavioral Memory Test（RBMT）
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 posted26 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 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
- 40 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
- NCT06386614
- Sponsor's protocol ID
- BDNF
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 21 May 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 21 May 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
- NCT06386614
- Acronym / sponsor ID
- BDNF
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 26 Apr 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.
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 the relationship between BDNF level and cognitive function] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level
Detailed description
- To study the therapeutic effect of transcranial direct current stimulation (tDCS) on post-stroke cognitive impairment (PSCI) by evaluating cognitive function and detecting plasma brain-derived neurotrophic factor (BDNF).
- To explore the correlation between plasma BDNF level and cognitive function in patients with PSCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| common group routine training | Sham comparator | Other: Routine treatmentConventional rehabilitation |
| tDCS group | Experimental | Other: Routine treatment, Other: Transcranial Direct Current StimulationConventional rehabilitation plus TDCS treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1)Stroke patients with CT or MRI imaging evidence, among which ischemic stroke met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and cerebral hemorrhage diseases met the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Cerebral hemorrhage 2019; (2) There are symptoms related to cognitive dysfunction; Cognitive dysfunction was assessed by rehabilitation physicians. According to the MoCA evaluation standard,MoCA score ≤26 points; according to the MMSE evaluation standard, illiteracy score ≤17 points; primary school education level ≤20 points; secondary school education (including secondary school) level ≤22 points; college education (including junior college) level ≤23 points; (3)Age range 40-80 years old; (4) no obvious aphasia, speech expression and attention can cooperate with the completion of evaluation and treatment; (5)The patient or the patient's family members read and agree to sign the informed consent.
Key exclusion criteria (1 listed)
- (1) Patients with severe diseases, such as malignant arrhythmia, acute myocardial infarction and acute heart failure, who cannot tolerate rehabilitation treatment; (2) Patients with untreated intracranial aneurysms, severe epilepsy, and intracranial metals who cannot receive tDCS treatment; (3) Non-PSCI patients with cognitive impairment, including patients with cognitive impairment left over from previous stroke and other organ disorders.
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 treatmentAlso: Routine medical treatment, basic rehabilitation training, individualized cognitive trainingBoth groups were given routine treatment | Other | common group routine training, tDCS group |
| Transcranial Direct Current StimulationThe common group routine training used sham TDCS stimulation, and the experimental group used real TDCS stimulation | Other | tDCS group |
Primary outcome
BDNF
Time frame: 2 weeks
Plasma BDNF was determined by elisa
3 secondary outcomes
Cognitive function level
Time frame: 2 weeks
Executive function level
Time frame: 2 weeks
Memory function level
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 21 May 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
2 sites 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 Transcranial Direct Current Stimulation in people with Stroke, run by The Second Affiliated Hospital of Dalian Medical University at 2 sites 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 1 inclusion and 1 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 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yang Tu (18875214238, 715700399@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF (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 21 May 2024.