Theta-burst temporal interference stimulation to improve awareness in people with disorders of consciousness
Effectiveness of Theta-Burst Patterned Temporal Interference Stimulation for Improving Awareness in Patients With Disorders of Consciousness: A Multicenter Randomized Double-Blind Controlled Trial
NA · Zhujiang Hospital · NCT07539740
This study will test whether theta-burst patterned temporal interference stimulation (tTIs) can help adults with recent disorders of consciousness (vegetative or minimally conscious) show more signs of awareness.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07539740 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults age 18–70 with a diagnosis of vegetative/unresponsive wakefulness or minimally conscious state of one year duration or less, who are medically stable, can undergo MRI/EEG, are not on sedative or interfering medications, and have no skull/brain implants or uncontrolled epilepsy.
Not a fit: Patients with disease duration over one year, uncontrolled seizures, incompatible implanted devices, prior neuropsychiatric disorders, or who cannot discontinue interfering medications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, tTIs could noninvasively increase signs of awareness and improve brain network function, offering a new treatment option for people with disorders of consciousness.
How similar studies have performed: Related invasive and noninvasive thalamic stimulation approaches have shown some promising but mixed results in restoring awareness, while theta-burst temporal interference stimulation is a novel technique with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Chengwei Xu
- Email: xuchweii@163.com
- Phone: 86+13450457096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Disorders of Consciousness, Vegetative State, Minimally Conscious State, Temporal Interference Stimulation, Theta-burst Patterned Stimulation, Deep Brain Stimulation, Thalamic Stimulation, Centromedian-parafascicular Nuclei