High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment (HOPE)

March 12, 2024 updated by: Zi-Xiao Li, Beijing Tiantan Hospital

High-frequency Repetitive Transcranial Magnetic Stimulation on the Cerebellar Hemisphere to Improve Post-stroke Cognitive Impairment

The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this clinical trial is to investigate the effectiveness and safety of high-frequency repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of high-frequency rTMS in improving post-stroke cognitive impairment? (2) Is high-frequency rTMS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo 5Hz rTMS in the cerebellar opposite the lesion site, once daily for a total of five days. The control group will receive sham rTMS with the same parameters and positions. By comparing the effectiveness of rTMS for post-stroke cognitive impairment between the two groups, researchers will assess the potential benefits of rTMS.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key inclusion criteria:

(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26;

Key exclusion criteria:

(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS group
5Hz rTMS in lesion contralateral cerebellar hemisphere
Device: rTMS group
5Hz rTMS in lesion contralateral cerebellar hemisphere, once a day for a total of five days
Placebo Comparator: control group
shame rTMS in lesion contralateral cerebellar hemisphere
Device: control group
shame rTMS in lesion contralateral cerebellar hemisphere, once a day for a total of five days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of rTMS in improving cognitive function of post-stroke cognitive impairment
Time Frame: 3 months follow-up after rTMS treatment
The change of MoCA between baseline and 3 months follow-up
3 months follow-up after rTMS treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of rTMS in improving cognitive function of post-stroke cognitive impairment
Time Frame: day1-day7
Incidence of epilepsy during rTMS treatment
day1-day7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Zixiao LI, Dr., Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX-A-2022063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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