Theta-burst temporal interference stimulation to improve awareness in people with disorders of consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, sham-controlled trial testing tTIs targeted to the centromedian-parafascicular (CM-pf) thalamic complex using MRI-guided placement. Participants receive either active tTIs or a sham procedure twice daily for five consecutive days (30 minutes per session, 10 sessions total) with 2 mA per channel (4 mA total) and theta-burst patterned pulses. Clinical awareness is measured before and after treatment using standardized scales (e.g., Coma Recovery Scale–Revised) and EEG to track changes in brain network function, with continuous safety monitoring. The trial compares active versus sham stimulation to determine whether tTIs produces greater behavioral and electrophysiological signs of improved consciousness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhujiang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chengwei Xu
• Email: xuchweii@163.com
• Phone: 86+13450457096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.