Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness
Primary Purpose
Disorder of Consciousness
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Consciousness focused on measuring TMS;DOC
Eligibility Criteria
Inclusion Criteria:
- 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);
5.DOC patients, including vegetative state and minimally consciousness state.
Exclusion Criteria:
- History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- with a contraindication for rTMS
Sites / Locations
- Hangzhou Hospital of Zhejiang CAPRRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
real-sham
sham-real
Arm Description
the group first received real rTMS,then sham one.
the group first received sham rTMS,then real one.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 α and β is related to the chance of recovery.
Full Information
NCT ID
NCT03385278
First Posted
October 24, 2017
Last Updated
December 20, 2017
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03385278
Brief Title
Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
TMS;DOC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real-sham
Arm Type
Experimental
Arm Description
the group first received real rTMS,then sham one.
Arm Title
sham-real
Arm Type
Experimental
Arm Description
the group first received sham rTMS,then real one.
Intervention Type
Other
Intervention Name(s)
rTMS
Intervention Description
20HZ Repetitive Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Description
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.
Time Frame
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 Outcome Measure Information:
Title
EEG data ( electrophysiological parameters)
Description
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.
Time Frame
at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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);
5.DOC patients, including vegetative state and minimally consciousness state.
Exclusion Criteria:
History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
with a contraindication for rTMS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Wu
Email
18826401709@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Benyan Luo
Email
luobenyan@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benyan Luo
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou Hospital of Zhejiang CAPR
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Wu
Email
18826401709@163.com
First Name & Middle Initial & Last Name & Degree
Kehong Liu
First Name & Middle Initial & Last Name & Degree
Jian Gao
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26301875
Citation
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.
Results Reference
background
PubMed Identifier
29770146
Citation
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.
Results Reference
derived
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Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness
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