Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness
NCT ID: NCT06527573
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
84 participants
INTERVENTIONAL
2024-07-30
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
tDCS and rTMS in Patients With Early Disorders of Consciousness
NCT05820178
Effects of Individualized rTMS in DOC Patients
NCT05187000
Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness
NCT03385278
rTMS and EEG in DOC Patients
NCT04401319
Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury
NCT06288984
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active repetitive transcranial magnetic stimulation on prefrontal lobes
Real stimulation will be delivered on individualized target using a real coil
active repetitive transcranial magnetic stimulation
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).
Active repetitive transcranial magnetic stimulation on posterior parietal lobes
Real stimulation will be delivered on individualized target using a real coil
active repetitive transcranial magnetic stimulation
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 stimulation
Sham stimulation will be delivered on individualized target using a sham coil
sham repetitive transcranial magnetic stimulation
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
active repetitive transcranial magnetic stimulation
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 stimulation
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. clinical diagnosis of DOC Disease;
3. no medical history of neuropsychiatric diseases;
4. 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;
5. stable state of disease and vital signs;
6. the integrity of the individualized stimulation target cortex are verified by MRI.
Exclusion Criteria
2. motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
3. uncontrolled epilepsy, seizure within 4 weeks before enrollment;
4. metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhujiang Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qiuyou Xie
principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangzhou, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
L20240725
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.