NCT05843240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

April 20, 2023

Last Update Submit

April 28, 2025

Conditions

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

rTMS

ACTIVE COMPARATOR

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

Procedure: Repetitive transcranial magnetic stimulation

sham-rTMS

PLACEBO COMPARATOR

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

Procedure: Sham repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationPROCEDURE

After enrollment, patients received rTMS once a day for 5 consecutive days (stimulation plan: stimulation of M1 region on the affected side at 10Hz).

rTMS
Sham repetitive transcranial magnetic stimulationPROCEDURE

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.

sham-rTMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years, both sexes;
  • Clinically definite diagnosis of acute ischemic stroke;
  • Baseline National Institute of Health Stroke Scale (NIHSS) score ≤25;
  • Pre-onset modified Rankin Scale (mRS) score ≤1;
  • Randomized and initiated transcranial magnetic stimulation within 1 week of onset;
  • Subject or legal representative agreed to the treatment and signed the informed consent.

You may not qualify if:

  • Presence of a medical condition such as severe cognitive impairment or mental impairment;
  • Patients with serious physical diseases or who have had craniocerebral surgery;
  • Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors;
  • Pregnancy or breastfeeding;
  • 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.;
  • Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly;
  • life expectancy of ≤3 months or inability to complete the study for other reasons;
  • unwillingness to be followed up or poor treatment compliance;
  • 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;
  • Other conditions that the investigators deemed unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice President of First Hospital of Jilin University

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 6, 2023

Study Start

May 7, 2023

Primary Completion

March 3, 2024

Study Completion

June 3, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations

CN(1)