Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke

Transcranial Magnetic Stimulation Clinical Trial

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843240
• Other study ID #: TMSCA-AIS
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Description:

Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with ischemic stroke. The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Transcranial Magnetic Stimulation

Intervention

Procedure:
• Repetitive transcranial magnetic stimulation
After enrollment, patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).
• Sham repetitive transcranial magnetic stimulation
After enrollment, patients received sham-rTMS once a day for 5 consecutive days with the same parameters as the rTMS group, but the coil was rotated 90° away from the scalp.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

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