Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385278
• Other study ID #: TMS
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: December 20, 2017
• Start date: April 2015
• Est. completion date: February 2018

Study information

• Verified date: October 2017
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Min Wu
• Email: 18826401709[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorder of Consciousness

Intervention

Other:
• rTMS
20HZ Repetitive Transcranial Magnetic Stimulation

Locations

Country	Name	City	State
China	Hangzhou Hospital of Zhejiang CAPR	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EEG data ( electrophysiological parameters)	delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of a and ß is related to the chance of recovery.	at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2)