Post-stroke Cognitive ImpairmentHOPENCT06316557
HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
A study testing iTBS group in people with Post-stroke Cognitive Impairment and Ischemic Stroke, run by Zi-Xiao Li at 1 site in China.
Trial summary
The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Cognitive Impairment, Ischemic Stroke
- What is being tested?
- iTBS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26;
Who cannot join
- (1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan hospital
Beijing, 100070
Weili Jia, +86 13120207987, jiawl1994@163.com
Zixiao Li, Dr.
About this study
The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.
Read the detailed description
The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.
- Conditions
- Post-stroke Cognitive Impairment, Ischemic Stroke
- Being tested
- iTBS group, control group
- Keywords
- Post-stroke Cognitive Impairment, Repetitive transcranial magnetic stimulation, High-frequency, Cerebellar
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS groupDevice
iTBS on the contralesional cerebellum, twice a day for seven days
control groupDevice
shame stimulation on the contralesional cerebellum, twice a day for seven days
| Study group | Role | What they receive |
|---|---|---|
| iTBS group | Experimental | iTBS on the contralesional cerebellum Receives: Device: iTBS group |
| control group | Placebo comparator | shame stimulation on the contralesional cerebellum Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of improving cognitive function of post-stroke cognitive impairment
The change of MoCA between baseline and 3 months follow-up
Measured: 3 months follow-up after treatment
Secondary outcomes (1)
The safety of improving cognitive function of post-stroke cognitive impairment
Incidence of epilepsy during treatment
Measured: day1-day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Cognitive ImpairmentStudies 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
- Model description
- Multicenter Randomized Double-Blind Controlled Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zi-Xiao Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zi-Xiao Li, Beijing Tiantan Hospital
- Investigators
- Zixiao LI, Dr., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316557
- Sponsor's protocol ID
- HX-A-2022063
- Acronym
- HOPE
- Status last verified
- Jun 2025
- First submitted
- 12 Mar 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
- ClinicalTrials.gov ID
- NCT06316557
- Acronym / sponsor ID
- HOPE / HX-A-2022063
- Conditions
- Post-stroke Cognitive Impairment, Ischemic Stroke
- Keywords
- Post-stroke Cognitive Impairment, Repetitive transcranial magnetic stimulation, High-frequency, Cerebellar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zi-Xiao LiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 18 Mar 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 objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.
Detailed description
The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter Randomized Double-Blind Controlled Study
| Arm | Type | Receives |
|---|---|---|
| iTBS group | Experimental | Device: iTBS groupiTBS on the contralesional cerebellum |
| control group | Placebo comparator | Device: control groupshame stimulation on the contralesional cerebellum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26;
Key exclusion criteria (1 listed)
- (1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;
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 |
|---|---|---|
| iTBS groupiTBS on the contralesional cerebellum, twice a day for seven days | Device | iTBS group |
| control groupshame stimulation on the contralesional cerebellum, twice a day for seven days | Device | control group |
Primary outcome
The efficacy of improving cognitive function of post-stroke cognitive impairment
Time frame: 3 months follow-up after treatment
The change of MoCA between baseline and 3 months follow-up
1 secondary outcome
The safety of improving cognitive function of post-stroke cognitive impairment
Time frame: day1-day7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Zixiao LI, Dr. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS group in people with Post-stroke Cognitive Impairment and Ischemic Stroke, run by Zi-Xiao Li 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 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Jia, Dr. (+86 13120207987, jiawl1994@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of improving cognitive function of post-stroke cognitive impairment (time frame: 3 months follow-up after treatment). 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 2 Jul 2025.