Disorder of ConsciousnessNCT06527573
Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness
A study testing active repetitive transcranial magnetic stimulation in people with Disorder of Consciousness, run by Zhujiang Hospital at 1 site in China.
Trial summary
Disorders of consciousness are a state in which consciousness is affected by brain damage, resulting in dysfunctions in alertness, awareness, and behavior. Patients with disorders of consciousness can be categorized into coma, unresponsive arousal syndrome（UWS）, and minimally conscious states（MCS）. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- active repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acquired brain injuries less than 1 year and more than 28 days in DOC;
- clinical diagnosis of DOC Disease;
- no medical history of neuropsychiatric diseases;
- no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;
- stable state of disease and vital signs;
- the integrity of the individualized stimulation target cortex are verified by MRI.
Who cannot join
- patients in other non-invasive or invasive neuroregulation trials;
- motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
- uncontrolled epilepsy, seizure within 4 weeks before enrollment;
- metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangzhou, 510280
Ziqin Liao, BSC, 15079991339, ziqinliao1997@163.com
Qiuyou Xie, PhD, 13903019604, xqy7180@163.com
About this study
Official title: Targeting Anterior or Posterior, Where is Better for DOC
Disorders of consciousness are a state in which consciousness is affected by brain damage, resulting in dysfunctions in alertness, awareness, and behavior. Patients with disorders of consciousness can be categorized into coma, unresponsive arousal syndrome（UWS）, and minimally conscious states（MCS）. Common causes include craniocerebral trauma and non-craniocerebral trauma causes such as stroke and ischemic-hypoxic encephalopathy. The number of patients with disorders of consciousness is rapidly increasing worldwide and is not only affecting the lives of individuals and their families, but is becoming a serious public health threat.Transcranial magnetic stimulation uses an electromagnetic pulse to induce focalised neural depolarisation and firing. Repeated transcranial magnetic stimulation, compared with single pulse transcranial magnetic stimulation, can influence brain plasticity and cortical organisation through alterations of neuronal excitability and is now being used to improve consciousness and functional recovery in patients with disorders of consciousness. However, the optimization of TMS stimulation parameters has become one of the key factors affecting the therapeutic efficacy, especially the choice of treatment location.
Method:This study is a randomized double-blind controlled trial.And eighty-four patients are expected to be recruited and they will be randomly assigned in a 1:1:1 ratio to two test groups and one control group of 28 patients each.. Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments. Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS.
Discussion:This study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials
- Conditions
- Disorder of Consciousness
- Being tested
- active repetitive transcranial magnetic stimulation, sham repetitive transcranial magnetic stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active repetitive transcranial magnetic stimulationDevice
During the rTMS-active stage, treatment will be given for 7 consecutive days (two session daily). The participants will be placed in the semi-reclining position on either a normal chair or a wheelchair and each stimulation session will last 20 minutes with a frequency of 10 Hz (train duration: 1s; inter-train interval: 5s; 200 effective stimulation series; 2000 pulses at 90% of RMT).
sham repetitive transcranial magnetic stimulationDevice
The sham coil will be used which has no magnetic field to send to the cerebral cortex while appearing to be the same shape as the active coil, with good approximation of auditory feedback.(train duration: 1s; inter-train interval: 5s; 200 effective stimulation series; 0 pulses at 90% of RMT).
| Study group | Role | What they receive |
|---|---|---|
| Active repetitive transcranial magnetic stimulation on prefrontal lobes | Experimental | Real stimulation will be delivered on individualized target using a real coil Receives: Device: active repetitive transcranial magnetic stimulation |
| Active repetitive transcranial magnetic stimulation on posterior parietal lobes | Experimental | Real stimulation will be delivered on individualized target using a real coil Receives: Device: active repetitive transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Sham stimulation will be delivered on individualized target using a sham coil Receives: Device: sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R)
The CRS-R includes six items addressing auditory, visual, motor, oromotor, communication, and arousal processes, each with different response categories, and its total score is calculated considering the presence or absence of specific behavioral responses to sensory stimuli, with a range between 0 (worst) and 23 (best). Each item of CRS-R is in good agreement with the diagnostic and differential diagnostic criteria of VS/UWS, MCS and EMCS. The higher scores mean a better outcome.Secondary outcome
Measured: immediately after 7 days rTMS session
Secondary outcomes (2)
Change from Baseline Resting-State EEG
Based on the assumption that specific cortical oscillations indicate varying levels of thalamocortical integrity that has defined four dynamic regimes that build on the mesocircuit model, each detectable with EEG and corresponding to a thalamo cortical state that indicates progressive circuit recovery.These EEG types are labeled A-D (hence, ABCD model) .Later types (C, D) denote more progressive recovery (i.e., are "better") than earlier types, (A, B), which correspond to a quiescent thalamic state.
Measured: immediately after 7 days rTMS session
Change from Baseline TMS-EEG
Transcranial magnetic stimulation combined with electroencephalography (TMS-EEG) is an effective way to measure cortical activity..In this study, PCIst, a derivative version of PCI, PCIst was chosen as an alternative, which estimates the complexity of TMS perturbations by signal decomposition and recurrence quantification analysis (RQA)
Measured: immediately after 7 days rTMS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Jul 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiuyou Xie, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527573
- Sponsor's protocol ID
- L20240725
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Anterior or Posterior, Where is Better for DOC
- ClinicalTrials.gov ID
- NCT06527573
- Acronym / sponsor ID
- L20240725
- Conditions
- Disorder of Consciousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disorders of consciousness are a state in which consciousness is affected by brain damage, resulting in dysfunctions in alertness, awareness, and behavior. Patients with disorders of consciousness can be categorized into coma, unresponsive arousal syndrome（UWS）, and minimally conscious states（MCS）. Common causes include craniocerebral trauma and non-craniocerebral trauma causes such as stroke and ischemic-hypoxic encephalopathy. The number of patients with disorders of consciousness is rapidly increasing worldwide and is not only affecting the lives of individuals and their families, but is becoming a serious public health threat.Transcranial magnetic stimulation uses an electromagnetic pulse to induce focalised neural depolarisation and firing. Repeated transcranial magnetic stimulation, compared with single pulse transcranial magnetic stimulation, can influence brain plasticity and cortical organisation through alterations of neuronal excitability and is now being used to improve consciousness and functional recovery in patients with disorders of consciousness. However, the optimization of TMS stimulation parameters has become one of the key factors affecting the therapeutic efficacy, especially the choice of treatment location.
Method:This study is a randomized double-blind controlled trial.And eighty-four patients are expected to be recruited and they will be randomly assigned in a 1:1:1 ratio to two test groups and one control group of 28 patients each.. Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments. Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS.
Discussion:This study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active repetitive transcranial magnetic stimulation on prefrontal lobes | Experimental | Device: active repetitive transcranial magnetic stimulationReal stimulation will be delivered on individualized target using a real coil |
| Active repetitive transcranial magnetic stimulation on posterior parietal lobes | Experimental | Device: active repetitive transcranial magnetic stimulationReal stimulation will be delivered on individualized target using a real coil |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Device: sham repetitive transcranial magnetic stimulationSham stimulation will be delivered on individualized target using a sham coil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- acquired brain injuries less than 1 year and more than 28 days in DOC;
- clinical diagnosis of DOC Disease;
- no medical history of neuropsychiatric diseases;
- no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;
- stable state of disease and vital signs;
Key exclusion criteria (4 listed)
- patients in other non-invasive or invasive neuroregulation trials;
- motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
- uncontrolled epilepsy, seizure within 4 weeks before enrollment;
- metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active repetitive transcranial magnetic stimulationDuring the rTMS-active stage, treatment will be given for 7 consecutive days (two session daily). The participants will be placed in the semi-reclining position on either a normal chair or a wheelchair and each stimulation session will last 20 minutes with a frequency of 10 Hz (train duration: 1s; inter-train interval: 5s; 200 effective stimulation series; 2000 pulses at 90% of RMT). | Device | Active repetitive transcranial magnetic stimulation on posterior parietal lobes, Active repetitive transcranial magnetic stimulation on prefrontal lobes |
| sham repetitive transcranial magnetic stimulationThe sham coil will be used which has no magnetic field to send to the cerebral cortex while appearing to be the same shape as the active coil, with good approximation of auditory feedback.(train duration: 1s; inter-train interval: 5s; 200 effective stimulation series; 0 pulses at 90% of RMT). | Device | Sham repetitive transcranial magnetic stimulation |
Primary outcome
Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R)
Time frame: immediately after 7 days rTMS session
The CRS-R includes six items addressing auditory, visual, motor, oromotor, communication, and arousal processes, each with different response categories, and its total score is calculated considering the presence or absence of specific behavioral responses to sensory stimuli, with a range between 0 (worst) and 23 (best). Each item of CRS-R is in good agreement with the diagnostic and differential diagnostic criteria of VS/UWS, MCS and EMCS. The higher scores mean a better outcome.Secondary outcome
2 secondary outcomes
Change from Baseline Resting-State EEG
Time frame: immediately after 7 days rTMS session
Change from Baseline TMS-EEG
Time frame: immediately after 7 days rTMS session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active repetitive transcranial magnetic stimulation in people with Disorder of Consciousness, run by Zhujiang Hospital 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?
The sponsor lists 6 inclusion and 4 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ziqin Liao, BSc (15079991339, ziqinliao1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline JFK Coma Recovery Scale-Revised(CRS-R) (time frame: immediately after 7 days rTMS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.