AzTrials
AzTrials

Disorder of ConsciousnessNCT05682248

Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness

A study testing Transcranial magnetic stimulation in people with Disorder of Consciousness, run by Xuanwu Hospital, Beijing at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness. Read more about this study

Who is it for?
Ages 14 to 80 years
Conditions the study is for
Disorder of Consciousness
What is being tested?
Transcranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteChina
Study dates
13 Apr 2022to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Admission criteria for patients with prolonged disorders of consciousness (Total 200) Inclusion Criteria:(1)Age 14-80 years;(2)In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;(3)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(4) right-handed；(5)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements;

Admission criteria for patients with acute disorders of consciousness(Total 300) Inclusion Criteria:（1)Age 14-60 years;（2）Meets diagnostic criteria for coma recognized in international studies；(3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;(5) right-handed；(6)The patient's family members signed the informed consent form; Exclusion Criteria:(1)The history of mental illness and a history of hearing impairment;(2)Intracranial arterial clamp, pacemaker and other metal implants; (3)During the experiment, sedatives and other drugs that affect the excitability of the cortex;(4)The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;(5)No spontaneous breathing;(6)Status Epilepticus;(7)Need emergency neurosurgical treatment can not cooperate with the examination;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Xuan Wu hospitial, capical medical university

    Beijing

Other trials in China

About this study

Official title: Science and Technology Innovation 2030

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

Read the detailed description

Analyzed the EEG activity and brain network changes before and after stimulation by TMS stimulation of key brain regions, and correlated them with brain function. To verify the "time-frequency-space" neural mechanism of consciousness.

Being tested
Transcranial magnetic stimulation, Sham Transcranial magnetic stimulation
Keywords
TMS, Non-invasive neuromodulation, Brain Function Test
Medical subject headings
Consciousness Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial magnetic stimulationDevice

    Transcranial magnetic stimulation

  • Sham Transcranial magnetic stimulationDevice

    Sham Transcranial magnetic stimulation

Study groups in NCT05682248
Study groupRoleWhat they receive
Real rTMS groupExperimentalTrue rTMS stimulation: 10Hz, intensity: 90% RMT, duration: 10s, interval: 30s, stimulation cycle: 1 time/day, treatment duration: 10 days;
Receives: Device: Transcranial magnetic stimulation
Sham rTMS groupPlacebo comparatorsham stimulation group : intensity :0; other parameters are the same as true rTMS stimulation
Receives: Device: Sham Transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Coma recovery scale-revised（CRS-R）

    CRS-R scale includes 6 dimensions such as audiovisual, arousal level, verbal response, motor and communication, scoring 0 to 23, the higher the score the better the neurological function, and each score reflects the presence or absence of the evaluated person and the strength of consciousness

    Measured: Assessment within 24 hours before, and 1 hour after TMS treatment

  2. Change from the p300 in electroencephalogram

    Assessment the p300 in event related potential(ERP)

    Measured: Assessment within 24 hours before, and 1 hour after TMS treatment

  3. Change from resting-state in electroencephalogram

    Assessment the spectral power and coherence by in resting-state EEG

    Measured: Assessment within 24 hours before, and 1 hour after TMS treatment

  4. Change from TEP in electroencephalogram

    Assessment the TMS Evoked Potential(TEP)

    Measured: Assessment within 24 hours before, and 1 hour after TMS treatment

  5. Change from PCI in electroencephalogram

    Assessment the perturbational complexity index(PCI) in TMS-EEG

    Measured: Assessment within 24 hours before, and 1 hour after TMS treatment

  6. Change from ROI in neuroimage techniques-PET

    The distribution of 18F-FDG in the brain was analyzed according to the imaging situation, and the brain regions of interest (ROI) were outlined, and the uptake of 18F-deoxyglucose (FDG) in the patients was observed according to the brain ROI.

    Measured: Assessment within 24 hours before ,and 1 hour after TMS treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start13 Apr 2022
  3. Primary completionAug 2024 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682248
Sponsor's protocol ID
2021ZD0204305
Status last verified
Dec 2023
First submitted
13 Nov 2022
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation in people with Disorder of Consciousness, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Coma recovery scale-revised（CRS-R） (time frame: Assessment within 24 hours before, and 1 hour after TMS treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05682248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in