Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

NCT03385278 | Unknown DMC

• 1 other identifier: TMS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disorder of Consciousness

Keywords

TMS;DOC

Outcome Measures

Primary Outcomes (1)

• the JFK Coma Recovery Scale-Revised (CRS-R) scale

  The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

  at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation.

Secondary Outcomes (1)

• EEG data ( electrophysiological parameters)

  at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2)

Study Arms (2)

real-sham

EXPERIMENTAL

the group first received real rTMS,then sham one.

Other: rTMS

sham-real

EXPERIMENTAL

the group first received sham rTMS,then real one.

Other: rTMS

Interventions

rTMS OTHER

20HZ Repetitive Transcranial Magnetic Stimulation

real-sham; sham-real

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 14 to 65 years old;
• no centrally acting drugs;
• no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);
• DOC patients, including vegetative state and minimally consciousness state.

You may not qualify if:

• History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
• with a contraindication for rTMS

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Hangzhou Hospital of Zhejiang CAPR

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26301875 BACKGROUND

• 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.

  PMID: 29770146 DERIVED

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Wu

CONTACT

18826401709@163.com

Benyan Luo

CONTACT

luobenyan@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: December 28, 2017
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 28, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)