RecruitingNot ApplicableNCT07539740

Effectiveness of tTIs for Improving Consciousness in Patients With DoC

Effectiveness of Theta-Burst Patterned Temporal Interference Stimulation for Improving Awareness in Patients With Disorders of Consciousness: A Multicenter Randomized Double-Blind Controlled Trial

Sponsor

Zhujiang Hospital

Enrollment

136 participants

Start Date

Mar 8, 2026

Study Type

INTERVENTIONAL

Conditions

Disorders of Consciousness Minimally Conscious State Vegetative State

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria5

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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Interventions

DEVICETheta-burst Patterned Temporal Interference Stimulation (tTIs)

The intervention targets the CM-pf complex using two pairs of high-frequency electrodes. Carrier frequency f1 = 2 kHz and f2 = 2.1 kHz to generate a 100 Hz interference. The stimulation is delivered in theta-burst patterns (3-pulse bursts at 100 Hz, repeated at 5 Hz). Sessions last 30 minutes, administered twice daily for 5 consecutive days (totaling 10 sessions). Current intensity is 2 mA per channel.

DEVICESham Temporal Interference Stimulation

The sham group uses the same device and electrode configuration as the active group. The device delivers 0 mA current after a 30-second ramp-up to mimic skin sensation. Sessions last 30 minutes, administered twice daily for 5 consecutive days (totaling 10 sessions).