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Magnetic brain stimulation paired with arm training after stroke

Tests magnetic brain stimulation with arm training in adults recovering from stroke.

Key facts

Who runs it: First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Where: Shanghai, ChinaSee the site
Trial code: NCT06849505
Registry title: Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation
Status: Recruiting
People taking part: 15 people, planned
Started: 2 Jul 2024
Planned end: 30 Jun 2025
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: online rTMS
offline rTMS
sham rTMS
Record updated: 27 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 20 to 80 who had a first stroke and have some weakness or movement problems in the arm or hand. Everyone gets magnetic brain stimulation (real or sham) along with movement training.

Age: 20 to 80 years
Sex: All sexes can join.
Disease stage: First diagnosed stroke, confirmed by a neurological exam, CT or MRI scan. Vital signs must be stable, with some upper limb movement problem.

Main reasons for not taking part

Severe heart, lung, liver or kidney disease, or a malignant tumor
History of aphasia, severe thinking problems or mental illness
Epileptic seizure in the last month, or recent use of anti-epileptic drugs
Metal in the brain, pacemaker, skull defect or other reason TMS cannot be done
Serious complications such as pneumonia, heart failure, urinary tract infection or malnutrition

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

The patient is first diagnosed with stroke through neurological examination, CT or MRI scan
The vital signs are stable and there is a certain degree of upper limb motor dysfunction
The age is between 20 and 80 years old
The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points
There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition)
There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures)
The patient or guardian agrees to sign the informed consent form

Who cannot take part

Patients with severe heart, lung, liver, kidney diseases and malignant tumors
Those with a history of aphasia, severe cognitive impairment or mental illness
Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently
People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS
Those with severe visual or hearing impairments, unable to communicate normally

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 20 and 80 years old?

Where in China

First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical UniversityShanghai, ChinaContact: Jia Min LiTaking people

About the trial

What the trial wants to find out

The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of individualized online rTMS intervention methods. The main questions it aims to answer are:

Read full original descriptionShow less

Does rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)？ Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials.

Participants will:

randomized to one group acoording to the MEP condition of each person; receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.

The 3 groups in the trial

online rTMSTreatment being tested
In the online stimulation group, the TMS treatment will continuously adjust the TMS parameters according to the baseline data and the data changes during the treatment to achieve personalized intervention. When patients receive TMS treatment, it is combined with upper limb movement tasks. When the task starts autonomously, TMS stimulation is triggered through electromyographic feedback. When the task stops or is completed, the TMS stimulation also stops immediately according to the electromyographic feedback, achieving real - time effects.
offline rTMSExisting treatment, for comparison
For the offline stimulation group, TMS treatment will be carried out before the task starts. After the stimulation ends, the subjects will then complete the task.
sham rTMSSham treatment, for comparison
Patients in the sham group also receive sham stimulation treatment combined with specific tasks, which is the same as the online stimulation group, except that the TMS stimulation is sham stimulation.