NCT07539740 Effectiveness of tTIs for Improving Consciousness in Patients With DoC
| NCT ID | NCT07539740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Disorders of Consciousness |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2026-03-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 136 participants in total. It began in 2026-03-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 physical exams to check their level of awareness before and after the 5 days of treatment. Have their progress followed by researchers through phone calls at 1, 3, and 6 months after the treatment ends.
Eligibility Criteria
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.
Contact & Investigator
Qiuyou Xie
STUDY CHAIR
Zhujiang Hospital
Frequently Asked Questions
Who can join the NCT07539740 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Disorders of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07539740 currently recruiting?
Yes, NCT07539740 is actively recruiting participants. Contact the research team at xuchweii@163.com for enrollment information.
Where is the NCT07539740 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07539740 clinical trial?
NCT07539740 is sponsored by Zhujiang Hospital. The principal investigator is Qiuyou Xie at Zhujiang Hospital. The trial plans to enroll 136 participants.