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Effectiveness of tTIs for Improving Consciousness in Patients With DoC

RecruitingNAAges 18 Years - 70 YearsAllZhujiang Hospital
NCT07539740 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if a new type of brain stimulation called theta-burst patterned temporal interference stimulation (tTIs) works to improve awareness in people with disorders of consciousness (DoC). The main questions it aims to answer are: 1. Does tTIs help people with disorders of consciousness show more signs of awareness? 2. Does tTIs improve the brain's ability to process information and connect different brain areas? Is tTIs safe and easy for people with disorders of consciousness to tolerate? Researchers will compare a group receiving active tTIs to a group receiving a "sham" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better. Participants will:Receive either active tTIs or sham stimulation twice a day for 5 consecutive days (total of 10 sessions). Undergo brain activity tests (EEG) and physi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 18 to 70 years old. * Condition: Patients diagnosed with Disorders of Consciousness (DoC), including Vegetative State (VS)/Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS) according to international guidelines. * Duration: Disease course ≤ 1 year.Medical History: No history of neuro-psychiatric disorders prior to the brain injury. * Handedness: Right-handed.Safety: No contraindications for tTIs, EEG, or MRI. * Medication: Not currently using sedative drugs or medications that interfere with brain stimulation, such as Na2+ or Ca2+ channel blockers, or NMDA receptor antagonists. Exclusion Criteria: * Concurrent Trials: Participation in other non-invasive or invasive neuromodulation trials. * Epilepsy: Uncontrolled epilepsy, defined as a seizure within 4 weeks prior to enrollment. * Implants: Presence of metal implants in the skull, brain pacemakers, or implanted brain devices (e.g., spinal cord stimulator). * Structural Issues: Skull defects at the site of stimulation that prevent the implementation of tTIs. * Systemic Implants: Presence of systemic metal implants, such as cardiac pacemakers.
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What it tests

  • Theta-burst Patterned Temporal Interference Stimulation (tTIs)
  • Sham Temporal Interference Stimulation
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Where

1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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