Temporal interference stimulation for people with severe disorders of consciousness

Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders

This trial will test whether non‑invasive temporal interference stimulation can help adults (18–75) who have been in a minimally conscious or vegetative state for at least 28 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06896279 on ClinicalTrials.gov

What this trial studies

The trial uses temporal interference (TI), a non‑invasive method that applies two high‑frequency currents to produce a low‑frequency envelope targeting deep brain regions, and compares active TI to a sham stimulation. Eligible patients are adults with prolonged disorders of consciousness (minimally conscious state or vegetative state ≥28 days), medically stable, and able to undergo MRI. Treatments are delivered at participating centers in Shanghai with clinical and safety monitoring to record changes in consciousness and adverse events. The design aims to characterize both potential benefits on recovery and the safety profile of TI stimulation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 in a minimally conscious or vegetative state lasting 28 days or more, who are medically stable, MRI‑compatible, and whose legal representatives provide informed consent.

Not a fit: Patients with major organ failure, significant neuropsychiatric comorbidities, prior intracranial hardware (e.g., V‑P shunt or Ommaya reservoir) that affects MRI, or unstable medical status are excluded and may not benefit from this intervention.

Why it matters

Potential benefit: If successful, TI stimulation could offer a non‑surgical way to stimulate deep brain areas and potentially improve consciousness and communication in some patients.

How similar studies have performed: Surgical deep brain stimulation has helped some patients but carries significant risks, while temporal interference is a novel, non‑invasive approach with promising preclinical work and only limited early human data so far.

Eligibility criteria

Inclusion Criteria:

* Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender;
* Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more;
* Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination;
* Written informed consent obtained from the patient's family members in advance.

Exclusion Criteria:

* Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney;
* Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals;
* Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future;
* Pregnant women;
* Those who have participated in other drug or device clinical trials;
* Patients with poorly controlled epilepsy in the recent period;
* Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site;
* Those currently taking medications prone to inducing epilepsy, such as quinolone drugs;
* Those with intracranial infections, intracranial tumors, or metallic objects within the cranium;
* Those allergic to electrode gel or adhesives;
* Those with implanted electronic devices within the body;
* Those with severe cardiac disorders and those equipped with cardiac pacemakers.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
• Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xuehai Wu, Ph.D. — Department of Neurosurgery, Huashan Hospital, Fudan University
• Study coordinator: Xuehai Wu, Ph.D.

Conditions Disorder of Consciousness; Temporal Interference Stimulation; Randomized clinical trail