Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness
Targeting Anterior or Posterior, Where is Better for DOC
1 other identifier
interventional
84
1 country
1
Brief 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）. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
July 30, 2024
July 1, 2024
1.9 years
July 25, 2024
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
immediately after 7 days rTMS session
Secondary Outcomes (2)
Change from Baseline Resting-State EEG
immediately after 7 days rTMS session
Change from Baseline TMS-EEG
immediately after 7 days rTMS session
Study Arms (3)
Active repetitive transcranial magnetic stimulation on prefrontal lobes
EXPERIMENTALReal stimulation will be delivered on individualized target using a real coil
Active repetitive transcranial magnetic stimulation on posterior parietal lobes
EXPERIMENTALReal stimulation will be delivered on individualized target using a real coil
Sham repetitive transcranial magnetic stimulation
SHAM COMPARATORSham stimulation will be delivered on individualized target using a sham coil
Interventions
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).
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangzhou, 510280, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 30, 2024
Study Start
July 30, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share