Disorders of ConsciousnessNCT06822192
The Temporally Interfering in Patients With Disorders of Consciousness
A study testing real TI in people with Disorders of Consciousness, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- real TI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In accordance with the international diagnostic criteria for MCS formulated by Giacino in 2002 or the diagnostic criteria for UWS proposed by Laureys in 2010; Patients with disease duration ≥28 days and unconscious improvement tendency in the past one month; No use of any sedative drugs or antiepileptic drugs (sodium or calcium channel blockers) in the past 1 month; stable vital signs; No obvious brain edema, hydrocephalus, and severe brain atrophy; Age from 18 to 80 years old; Informed consent was obtained from the patients' family members.
Who cannot join
- Previous history of neurological or psychiatric disorders; Prior traumatic brain injury unrelated to the index injury; History of cancer; Taking sedative drugs or antiepileptic drugs in the past 1 month; Unstable vital signs; Skull defect; The patients' family members did not sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou Mingzhou Brain Rehabilitation Hospital
Hangzhou, Zhejiang, 310000
About this study
Official title: The Efficacy and Safety of Temporally Interfering in Patients With Disorders of Consciousness
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
- Conditions
- Disorders of Consciousness
- Being tested
- sham TI, real TI
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham TIDevice
The sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period.
real TIDevice
Stimulation was delivered as two sinusoidal alternating currents with carrier frequencies of 2000 Hz and 2010 Hz, generating a 10 Hz amplitude-modulated envelope. Current intensity was set at 3 mA per channel. Each session included 30-second ramp-up and ramp-down periods at the beginning and end of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Sham comparator | Sham comparator | Participants receive sham TI stimulation one session per day for 5 consecutive days Receives: Device: sham TI |
| real TI stimulation | Active comparator | Participants receive real TI stimulation one session per day for 5 consecutive days Receives: Device: real TI |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS-R (Coma Recovery Scale-revised)
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Measured: Baseline; Within 1 week post-stimulation
Secondary outcomes (8)
EEG spectral power
EEG spectral power was quantified across five canonical frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz). Relative power spectral density (PSD) was calculated for each frequency band.
Measured: Baseline; Within 1 week post-stimulation
fNIRS-derived hemoglobin concentration changes
Changes in oxygenated hemoglobin (ΔHbO), deoxygenated hemoglobin (ΔHbR), and total hemoglobin (ΔHbT) concentrations were measured using functional near-infrared spectroscopy (fNIRS).
Measured: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
GOS-E（Glasgow Outcome Scale - Extended）
The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.
Measured: 6 months
Changes in CRS-R subscale scores
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Measured: Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
Total CRS-R score changes at follow-up
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
Measured: Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
EEG functional connectivity
EEG functional connectivity was quantified using phase-locking value (PLV) across five frequency bands: delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-40 Hz).
Measured: Baseline; Within 1 week post-stimulation
Auditory steady-state response (ASSR)
ASSR was recorded during EEG while participants listened to modulated tones. ASSR strength was quantified using an amplitude-based signal-to-noise ratio (SNR), calculated as the amplitude at the target frequency divided by the mean amplitude of the surrounding spectral background.
Measured: Baseline; Within 1 week post-stimulation
fNIRS-derived functional connectivity
Functional connectivity was estimated by calculating Pearson correlation coefficients between fNIRS time series.
Measured: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start20 Jan 2025
- Primary completion31 Oct 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Hangzhou Mingzhou Brain Rehabilitation Hospital
- Responsible party
- Principal investigator, Li Zhang, MD, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822192
- Sponsor's protocol ID
- TI-DOC
- Status last verified
- May 2026
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023.
PubMed 37780965Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12.
PubMed 39133053
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Temporally Interfering in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06822192
- Acronym / sponsor ID
- TI-DOC
- Conditions
- Disorders of Consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Hangzhou Mingzhou Brain Rehabilitation Hospital
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 12 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.
This project will help the patient recover consciousness by giving TI (temporally interfering) treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham comparator | Sham comparator | Device: sham TIParticipants receive sham TI stimulation one session per day for 5 consecutive days |
| real TI stimulation | Active comparator | Device: real TIParticipants receive real TI stimulation one session per day for 5 consecutive days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In accordance with the international diagnostic criteria for MCS formulated by Giacino in 2002 or the diagnostic criteria for UWS proposed by Laureys in 2010; Patients with disease duration ≥28 days and unconscious improvement tendency in the past one month; No use of any sedative drugs or antiepileptic drugs (sodium or calcium channel blockers) in the past 1 month; stable vital signs; No obvious brain edema, hydrocephalus, and severe brain atrophy; Age from 18 to 80 years old; Informed consent was obtained from the patients' family members.
Key exclusion criteria (1 listed)
- Previous history of neurological or psychiatric disorders; Prior traumatic brain injury unrelated to the index injury; History of cancer; Taking sedative drugs or antiepileptic drugs in the past 1 month; Unstable vital signs; Skull defect; The patients' family members did not sign the informed consent.
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 |
|---|---|---|
| sham TIThe sham TI device is the same as the active comparator's except that no current was delivered during the stimulation period. | Device | Sham comparator |
| real TIStimulation was delivered as two sinusoidal alternating currents with carrier frequencies of 2000 Hz and 2010 Hz, generating a 10 Hz amplitude-modulated envelope. Current intensity was set at 3 mA per channel. Each session included 30-second ramp-up and ramp-down periods at the beginning and end of stimulation. | Device | real TI stimulation |
Primary outcome
CRS-R (Coma Recovery Scale-revised)
Time frame: Baseline; Within 1 week post-stimulation
The CRS-R scale, with scores ranging from 0 to 23, a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
8 secondary outcomes
EEG spectral power
Time frame: Baseline; Within 1 week post-stimulation
fNIRS-derived hemoglobin concentration changes
Time frame: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
GOS-E（Glasgow Outcome Scale - Extended）
Time frame: 6 months
Changes in CRS-R subscale scores
Time frame: Baseline; Within 1 week post-stimulation and at 1-month, 3-month, and 6-month follow-up.
Total CRS-R score changes at follow-up
Time frame: Pre-stimulation, post-stimulation and at 1-month, 3-month, and 6-month follow-up.
EEG functional connectivity
Time frame: Baseline; Within 1 week post-stimulation
Auditory steady-state response (ASSR)
Time frame: Baseline; Within 1 week post-stimulation
fNIRS-derived functional connectivity
Time frame: fNIRS data were acquired over a 40-min session on each of the 5 treatment days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Results publication: PubMed 37780965Zhu Z, Yin L. A mini-review: recent advancements in temporal interference stimulation in modulating brain function and behavior. Front Hum Neurosci. 2023 Sep 14;17:1266753. doi: 10.3389/fnhum.2023.1266753. eCollection 2023.
- Results publication: PubMed 39133053Yang C, Xu Y, Feng X, Wang B, Du Y, Wang K, Lu J, Huang L, Qian Z, Wang Z, Chen N, Zhou J, Zhang C, Liu Y. Transcranial Temporal Interference Stimulation of the Right Globus Pallidus in Parkinson's Disease. Mov Disord. 2025 Jun;40(6):1061-1069. doi: 10.1002/mds.29967. Epub 2024 Aug 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real TI in people with Disorders of Consciousness, run by Zhejiang Provincial People's Hospital at 1 site 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: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS-R (Coma Recovery Scale-revised) (time frame: Baseline; Within 1 week post-stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06822192, which also lists 2 linked publications.
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 22 Jul 2026.