Transcranial Magnetic Stimulation Clinical Trial
Official title:
Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke
NCT number | NCT05843240 |
Other study ID # | TMSCA-AIS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 7, 2023 |
Est. completion date | June 30, 2024 |
The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years, both sexes; 2. Clinically definite diagnosis of acute ischemic stroke; 3. Baseline National Institute of Health Stroke Scale (NIHSS) score =25; 4. Pre-onset modified Rankin Scale (mRS) score =1; 5. Randomized and initiated transcranial magnetic stimulation within 1 week of onset; 6. Subject or legal representative agreed to the treatment and signed the informed consent. Exclusion Criteria: 1. Presence of a medical condition such as severe cognitive impairment or mental impairment; 2. Patients with serious physical diseases or who have had craniocerebral surgery; 3. Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors; 4. Pregnancy or breastfeeding; 5. The presence of metal foreign bodies near the stimulation site, such as intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers), etc.; 6. Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly; 7. life expectancy of =3 months or inability to complete the study for other reasons; 8. unwillingness to be followed up or poor treatment compliance; 9. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study; 10. Other conditions that the investigators deemed unsuitable for enrollment. |
Country | Name | City | State |
---|---|---|---|
China | The First Hospital of Jilin University | Changchun | Jilin |
Lead Sponsor | Collaborator |
---|---|
Yi Yang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | phase difference(PD) in degree | A cerebral autoregulation parameter derived from transfer function analysis. Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the cerebral autoregulatory parameter. | 0-5 days |
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