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

Sponsor
Yi Yang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05843240
Collaborator
(none)
128
2
11.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Repetitive transcranial magnetic stimulation
  • Procedure: Sham repetitive transcranial magnetic stimulation
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke
Anticipated Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: rTMS

Patients are treated with repetitive transcranial magnetic stimulation (rTMS).

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).

Placebo Comparator: sham-rTMS

Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. phase difference(PD) in degree [0-5 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yi Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi Yang, Vice President of First Hospital of Jilin University, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT05843240
Other Study ID Numbers:
  • TMSCA-AIS
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023