NCT06851156RecruitingNot Applicable
An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
Xijing Hospital2 sites in 1 country10 target enrollmentStarted: April 7, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- CRS-R total score changes
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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)
Investigators
Study Sites (2)
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