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

NCT06851156 — Not applicable, Recruiting, 10 participants, Xijing Hospital

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An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness

Registry	NCT06851156
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Estimated)
Sponsor	Xijing Hospital (Other)
Conditions	Disorders of Consciousness, Severe Brain Injury, Unresponsive Wakefulness Syndrome, Minimally Conscious State
Interventions	tTIS (Device)
Dates	start 2025-04-07, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2025-02-28, last updated 2025-04-09
Locations	2 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Transcranial Temporal Interference Stimulation	Experimental	Device: tTIS	tTIS is applied over the bilateral CM-pf for 10 days, once a day.

tTIS (Device): CM-pf tTIS

+Outcome measures

Primary outcomes

CRS-R total score changes [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.

Secondary outcomes

Numbers of patients with improved consciousness [From enrollment to the end of treatment at 10 days]
EEG changes [From enrollment to the end of treatment at 10 days]: EEG power spectra, Connectivity and ABCD model, etc

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

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

+Locations (2)

Facility	City	Country	Status
Xijing Hospital	Xi'an, Shaanxi	China	Not yet recruiting
Xijing Hospital	Xi'an, Shaanxi	China	Recruiting

+Investigators

wen Jiang, phD, Principal investigator, Xijing Hospital