Could a zapping helmet wake the unresponsive?
NCT ID NCT07539740
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new, non-invasive brain stimulation method called theta-burst patterned temporal interference stimulation (tTIs) to see if it can improve awareness in people with disorders of consciousness, such as vegetative or minimally conscious states. About 136 adults will receive either real tTIs or a fake (sham) stimulation twice daily for 5 days. Researchers will measure changes in consciousness using standard behavioral scales and brain activity tests, and follow up for 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhujiang Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510280, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Gentle touch may reveal hidden awareness in unresponsive patients
- Can a gentle ear zap wake the brain after a bleed?
- Brain-wave test may predict who wakes up after severe brain injury
- Brain scans may reveal hidden signs of consciousness after severe injury
- Can a 'temporal interference' electric field nudge the brain back toward awareness?