ClinicalTrials.gg
Sign In
RecruitingNCT06851156Updated Apr 9, 2025

Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness

An interventional study of tTIS in Disorders of Consciousness, Severe Brain Injury and Unresponsive Wakefulness Syndrome, sponsored by Xijing Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.

02

Conditions studied

  • Disorders of Consciousness
  • Severe Brain Injury
  • Unresponsive Wakefulness Syndrome
  • Minimally Conscious State
03

In context

Consciousness Disorders

290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.

This study's planned enrollment of 10 is below the median of 47 across 191 interventional studies indexed under Consciousness Disorders.

Browse Consciousness Disorders studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Browse Xijing Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.

Exclusion criteria

Exclusion Criteria:

  • patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Transcranial Temporal Interference Stimulation

    tTIS is applied over the bilateral CM-pf for 10 days, once a day.

    Device: tTIS

Interventions

  • DevicetTIS

    CM-pf tTIS

06

What researchers measure

Primary outcomes

  1. CRS-R total score changes

    Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.

    Time frame: From enrollment to the end of treatment at 10 days

Secondary outcomes

  1. Numbers of patients with improved consciousness

    Time frame: From enrollment to the end of treatment at 10 days

  2. EEG changes

    EEG power spectra, Connectivity and ABCD model, etc

    Time frame: From enrollment to the end of treatment at 10 days

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Dec 2025, 8 months after the start.

Of 89 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 8 months is below that.

Counting every sponsor, half of 94 studies reached it within 19 months; a quarter within 8 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2025
First posted
Feb 28, 2025
StartActual
Apr 7, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06851156
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Feb 28, 2025
Start date
Apr 7, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 9, 2025

Study contacts

Gengyao Hu
Contact
304517021@qq.com
86-15399059833
wen Jiang, phD
principal investigator · Xijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Consciousness Disorders →

Other studies from this sponsor

Xijing Hospital →

Start the discussion