Clinical trial NCT06822192: The Temporally Interfering in Patients with Disorders of Consciousness
Official title: The Efficacy and Safety of Temporally Interfering in Patients with Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disorders of Consciousness
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will help the patient recover consciousness by giving TI (temporally interfering) treatment


Eligibility criteria: Inclusion Criteria:

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 70 years old; Informed consent was obtained from the patients' family members.

Exclusion Criteria:

Previous history of neurological or psychiatric disorders; Previous history of traumatic brain 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.

Primary outcomes:
measure: CRS-R (Coma Recovery Scale-revised)
timeFrame: One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
measure: Adverse reactions
timeFrame: One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
Secondary outcomes:
measure: EEG
timeFrame: One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
measure: fNIRS（functional near-infrared spectroscopy）
timeFrame: One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
measure: GOS-E（Glasgow Outcome Scale - Extended）
timeFrame: 2 weeks, 1 month, and 3 months after the end of stimulation
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Yang 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. 2024 Aug 12. doi: 10.1002/mds.29967. Online ahead of print.