Using transcranial magnetic stimulation to improve arm movement in stroke patients

Transcranial Magnetic Stimulation Synchronized with Specific Tasks Intervetnion on Upper Limb Motor Dysfunction in Stroke Patients

This study is testing if a special brain stimulation technique can help stroke patients improve their arm movement during rehabilitation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06752499 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation for stroke patients during the subacute and chronic phases. The study aims to determine if rTMS synchronized with motor training can improve rehabilitation outcomes for patients who can and cannot induce motor evoked potentials (MEPs). Participants will be randomly assigned to receive either individualized rTMS, non-individualized rTMS, or sham stimulation over a two-week period, with multiple motor tasks performed daily. The safety of the intervention will also be assessed throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have been diagnosed with stroke and exhibit upper limb motor dysfunction.

Not a fit: Patients with severe comorbidities or contraindications for TMS, such as those with significant cognitive impairment or a history of seizures, may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance motor recovery in stroke patients, improving their quality of life.

How similar studies have performed: Previous studies have shown promise with rTMS in stroke rehabilitation, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
3. The age is between 18 and 80 years old.
4. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
5. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
6. 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).
7. The patient or guardian agrees to sign the informed consent form.

Exclusion Criteria:

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

Where this trial is running

Shanghai, Shanghai

• Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yang LIU, Master of Medicine

Conditions Stroke; Upper Extremity Paresis; Repetitive Transcranial Magnetic Stimulation; Upper Limb Motor Dysfunction; online; motor task training; individualized; Motor evoked potentials