Disorders of ConsciousnessNCT06851156
Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness
A study testing tTIS in people with Disorders of Consciousness and Severe Brain Injury, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disorders of Consciousness, Severe Brain Injury, Unresponsive Wakefulness Syndrome
- What is being tested?
- tTIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 7 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Gengyao Hu, 86-029-84771794, customer@notice.rh-clinical.com
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
chairman of committee, 86-029-84771794, customer@notice.rh-clinical.com
About this study
Official title: An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
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.
- Conditions
- Disorders of Consciousness, Severe Brain Injury, Unresponsive Wakefulness Syndrome, Minimally Conscious State
- Being tested
- tTIS
- Medical subject headings
- Consciousness Disorders, Brain Injuries, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tTISDevice
CM-pf tTIS
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Temporal Interference Stimulation | Experimental | tTIS is applied over the bilateral CM-pf for 10 days, once a day. Receives: Device: tTIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 10 days
Secondary outcomes (2)
Numbers of patients with improved consciousness
Measured: From enrollment to the end of treatment at 10 days
EEG changes
EEG power spectra, Connectivity and ABCD model, etc
Measured: From enrollment to the end of treatment at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start7 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wen Jiang, phD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851156
- Sponsor's protocol ID
- KY20242231jiangwen
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06851156
- Acronym / sponsor ID
- KY20242231jiangwen
- Conditions
- Disorders of Consciousness, Severe Brain Injury, Unresponsive Wakefulness Syndrome, Minimally Conscious State
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Temporal Interference Stimulation | Experimental | Device: tTIStTIS is applied over the bilateral CM-pf for 10 days, once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tTISCM-pf tTIS | Device | Transcranial Temporal Interference Stimulation |
Primary outcome
CRS-R total score changes
Time frame: From enrollment to the end of treatment at 10 days
Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.
2 secondary outcomes
Numbers of patients with improved consciousness
Time frame: From enrollment to the end of treatment at 10 days
EEG changes
Time frame: From enrollment to the end of treatment at 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wen Jiang, phD principal investigator
Xijing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tTIS in people with Disorders of Consciousness and Severe Brain Injury, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gengyao Hu (86-15399059833, 304517021@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS-R total score changes (time frame: From enrollment to the end of treatment at 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.