Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

Not Applicable

• Conditions: Disorder of Consciousness
• Interventions: Other: rTMS

• Registration Number: NCT03385278
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2017-10
• Study First Submitted: 2017-10-24
• Primary Completion: 2017-12
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-28
• Last Update Posted: 2017-12-28
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
real-sham	rTMS	the group first received real rTMS,then sham one.
sham-real	rTMS	the group first received sham rTMS,then real one.

Primary Outcome Measures

Name	Time	Method
the JFK Coma Recovery Scale-Revised (CRS-R) scale	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.	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.

Secondary Outcome Measures

Name	Time	Method
EEG data ( electrophysiological parameters)	at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2)	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 α and β is related to the chance of recovery.

Trial Locations

Locations (1)

Hangzhou Hospital of Zhejiang CAPR; 🇨🇳 Hangzhou, Zhejiang, China