Effectiveness of tTIs for Improving Consciousness in Patients With DoC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhujiang Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Theta-burst Patterned Temporal Interference Stimulation (tTIs)
- Sham Temporal Interference Stimulation
Treatment groups
136 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov