Stroke IschemicNCT06415734
Effect of Repetitive Transcranial Magnetic Stimulation on Neurological Recovery in Patients With Ischaemic Stroke
A study testing rTMS in people with Stroke Ischemic, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are: Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke Ischemic
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Sep 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age range is 18~75 years old
- Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning
- Acute stage of the disease \<14 days and stable condition
- Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions)
- Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient.
- Subjects were right-handed
- Participants give their informed consent and sign an informed consent form
Who cannot join
- Those who have metal implants or any electronic devices in their body
- Those with previous epilepsy or mental abnormality.
- Combined with serious heart, liver, lung and other important organ failure
- Those who have brain haemorrhage or bleeding tendency.
- Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage.
- Patients with history of craniocerebral trauma and craniocerebral surgery.
- Those with severe cognitive and communication disorders who are unable to cooperate -
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029
18100613663, zhaoluwang@njmu.edu.cn
About this study
Official title: Repeated Transcranial Magnetic Stimulation (rTMS) Promotes Neural Function Recovery in Patients With Ischemic Stroke by Affecting Local Cerebral Blood Flow and Brain Network
The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are:
Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients?
Read more
Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke.
Participants will:
Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after treatment
- Conditions
- Stroke Ischemic
- Being tested
- rTMS
- Keywords
- rTMS, stroke Ischemic
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
LF-rTMS of M1 contralateral to the brain lesion for 20 min, 1200 pulses, 120% RMT, treatment cycle of 5 days
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Subjects were treated with transcranial magnetic stimulation with the addition of a figure-of-eight coil on top of conventional western medicine treatment, and the treatment modalities were all LF-rTMS 20 min, 1200 pulses, 120% RMT in M1 contralateral to the brain lesion, with a treatment cycle of 5 days. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. Receives: Device: rTMS |
| control | No intervention | Patients received only conventional Western medications. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patient motor function
Fugl-Meyer assessment scale，FMA Score: Minimum: 0 points, Maximum: 100 points The higher the score, the better the limb function.
Measured: Before patient treatment and 5 days after patient treatment
Secondary outcomes (1)
Altered functional connectivity of brain networks in patients
data from near-infrared functional brain imaging acquisitions
Measured: Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415734
- Sponsor's protocol ID
- 202405n
- Status last verified
- Jun 2024
- First submitted
- 10 May 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Transcranial Magnetic Stimulation (rTMS) Promotes Neural Function Recovery in Patients With Ischemic Stroke by Affecting Local Cerebral Blood Flow and Brain Network
- ClinicalTrials.gov ID
- NCT06415734
- Acronym / sponsor ID
- 202405n
- Conditions
- Stroke Ischemic
- Keywords
- rTMS, stroke Ischemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 16 May 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 goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are:
Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients?
Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke.
Participants will:
Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMSSubjects were treated with transcranial magnetic stimulation with the addition of a figure-of-eight coil on top of conventional western medicine treatment, and the treatment modalities were all LF-rTMS 20 min, 1200 pulses, 120% RMT in M1 contralateral to the brain lesion, with a treatment cycle of 5 days. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. |
| control | No intervention | –Patients received only conventional Western medications. And subjects will be assessed on the relevant scales on Day 1 and Day 5 of treatment and will be tested using a near infrared functional brain imaging device before, during and after treatment on that day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The age range is 18~75 years old
- Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning
- Acute stage of the disease \<14 days and stable condition
- Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions)
- Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient.
Key exclusion criteria (7 listed)
- Those who have metal implants or any electronic devices in their body
- Those with previous epilepsy or mental abnormality.
- Combined with serious heart, liver, lung and other important organ failure
- Those who have brain haemorrhage or bleeding tendency.
- Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage.
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 |
|---|---|---|
| rTMSLF-rTMS of M1 contralateral to the brain lesion for 20 min, 1200 pulses, 120% RMT, treatment cycle of 5 days | Device | rTMS |
Primary outcome
Improvement in patient motor function
Time frame: Before patient treatment and 5 days after patient treatment
Fugl-Meyer assessment scale，FMA Score: Minimum: 0 points, Maximum: 100 points The higher the score, the better the limb function.
1 secondary outcome
Altered functional connectivity of brain networks in patients
Time frame: Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Stroke Ischemic, run by The First Affiliated Hospital with Nanjing 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 7 inclusion and 7 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 18 Jun 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. 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 Zhaolu Wang (+86 18100613663, zhaoluwang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patient motor function (time frame: Before patient treatment and 5 days after patient 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 18 Jun 2024.