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Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

NCT ID: NCT03385278

Last Updated: 2017-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-02-28

Brief Summary

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Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.

Detailed Description

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Background:Repetitive transcranial magnetic stimulation (rTMS) was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.

Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of high-frequency rTMS in DOC.

Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.

Hypothesis:Real rTMS can be an effective awakening method.

Conditions

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Disorder of Consciousness

Keywords

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TMS;DOC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study was designed and performed as a randomized, controlled cross-over trial. All patients were randomly received active 20-Hz rTMS and sham stimulation for 5 consecutive days, in separate sessions spaced one week.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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real-sham

the group first received real rTMS,then sham one.

Group Type EXPERIMENTAL

rTMS

Intervention Type OTHER

20HZ Repetitive Transcranial Magnetic Stimulation

sham-real

the group first received sham rTMS,then real one.

Group Type EXPERIMENTAL

rTMS

Intervention Type OTHER

20HZ Repetitive Transcranial Magnetic Stimulation

Interventions

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rTMS

20HZ Repetitive Transcranial Magnetic Stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients ages 14 to 65 years old;
2. no centrally acting drugs;
3. no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);

5.DOC patients, including vegetative state and minimally consciousness state.

Exclusion Criteria

1. History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
2. with a contraindication for rTMS
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benyan Luo

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Zhejiang University

Locations

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Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Wu

Role: CONTACT

Email: [email protected]

Benyan Luo

Role: CONTACT

Email: [email protected]

Facility Contacts

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Min Wu

Role: primary

References

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Cincotta M, Giovannelli F, Chiaramonti R, Bianco G, Godone M, Battista D, Cardinali C, Borgheresi A, Sighinolfi A, D'Avanzo AM, Breschi M, Dine Y, Lino M, Zaccara G, Viggiano MP, Rossi S. No effects of 20 Hz-rTMS of the primary motor cortex in vegetative state: A randomised, sham-controlled study. Cortex. 2015 Oct;71:368-76. doi: 10.1016/j.cortex.2015.07.027. Epub 2015 Aug 4.

Reference Type BACKGROUND
PMID: 26301875 (View on PubMed)

He F, Wu M, Meng F, Hu Y, Gao J, Chen Z, Bao W, Liu K, Luo B, Pan G. Effects of 20 Hz Repetitive Transcranial Magnetic Stimulation on Disorders of Consciousness: A Resting-State Electroencephalography Study. Neural Plast. 2018 Mar 25;2018:5036184. doi: 10.1155/2018/5036184. eCollection 2018.

Reference Type DERIVED
PMID: 29770146 (View on PubMed)

Other Identifiers

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TMS

Identifier Type: -

Identifier Source: org_study_id