Actively Recruiting
Effects of Repetitive Transcranial Magnetic Stimulation Targeting Anterior or Posterior Brain Regions in Patients With Disorders of Consciousness
Led by Zhujiang Hospital · Updated on 2024-07-30
84
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Disorders of consciousness (DOC) affect alertness, awareness, and behavior due to brain damage, including coma, unresponsive arousal syndrome (UWS), and minimally conscious states (MCS). Common causes include brain trauma, stroke, and ischemic-hypoxic encephalopathy. The number of patients with DOC is rising worldwide, presenting serious challenges for patients, families, and public health. This research evaluates how repetitive transcranial magnetic stimulation (rTMS) with different stimulation spots may influence consciousness and recovery in DOC patients, using a randomized controlled trial design. The study involves 84 patients randomly assigned to three groups: two active rTMS groups receiving stimulation on either the prefrontal lobes or posterior parietal lobes, and a sham group receiving simulated stimulation. Each patient undergoes 14 rTMS sessions over 7 consecutive days, with two 20-minute sessions daily at 10 Hz frequency. The sham stimulation uses a coil that mimics the sound and appearance without delivering magnetic pulses. The trial aims to find the best brain target for rTMS treatment and to explore how rTMS affects brain activity and consciousness. Participants will have baseline and post-treatment evaluations including the Coma Recovery Scale-Revised (CRS-R) to measure behavioral responses, along with resting-state EEG and TMS-EEG to assess neurophysiological changes. Researchers will monitor patients closely during the week of treatment. This study helps advance knowledge on optimizing rTMS protocols and understanding consciousness mechanisms in DOC, with a total study duration of 7 days of treatment and immediate post-treatment assessments.
CONDITIONS
Brief Title
Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Acquired brain injuries between 28 days and 1 year prior with disorders of consciousness
- Clinical diagnosis of disorders of consciousness
- No history of neuropsychiatric diseases
- No sedatives or drugs interfering with brain stimulation
- Stable disease condition and vital signs
- Individualized stimulation target cortex verified by MRI
You will not qualify if you...
- Participation in other neuroregulation trials
- Motor evoked potential (MEP) cannot be induced in M1 region by TMS pulse
- Uncontrolled epilepsy or seizures within 4 weeks before enrollment
- Metallic implants in skull, pacemaker, craniotomy under stimulation site, or implanted brain devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 consecutive days
Participants receive repetitive transcranial magnetic stimulation targeting either anterior or posterior brain regions using a real or sham coil.
2 sessions daily for 7 days (in-person)
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangzhou, China, 510280
Actively Recruiting
Research Team
Z
ziqin Liao, BSc
Q
Qiuyou Xie, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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