Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis

NCT ID: NCT03163758

Last Updated: 2020-06-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2018-12-31

Brief Summary

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The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rTMS treatment group

The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.

Group Type EXPERIMENTAL

real Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.

sham group

The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.

Group Type SHAM_COMPARATOR

sham Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.

Interventions

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real Repetitive Transcranial Magnetic Stimulation

The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.

Intervention Type DEVICE

sham Repetitive Transcranial Magnetic Stimulation

The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image,
2. right-handed,
3. without memory loss or intelligence disorder,
4. never suffered stroke before.

Exclusion Criteria

1. direct damage to the cerebral cortex,
2. a history of cerebral vessel disease,
3. tendency to hemorrhage or existed brain hemorrhage,
4. epilepsy or other mental disorders,
5. any MRI contraindications.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Li J, Zuo Z, Zhang X, Shao X, Lu J, Xue R, Fan Y, Guan Y, Zhang W. Excitatory Repetitive Transcranial Magnetic Stimulation Induces Contralesional Cortico-Cerebellar Pathways After Acute Ischemic Stroke: A Preliminary DTI Study. Front Behav Neurosci. 2018 Jul 27;12:160. doi: 10.3389/fnbeh.2018.00160. eCollection 2018.

Reference Type DERIVED
PMID: 30140207 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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NNSFC-81271545

Identifier Type: -

Identifier Source: org_study_id

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