Actively Recruiting
An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness
Led by Xijing Hospital · Updated on 2025-04-09
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of noninvasive neuromodulation using transcranial temporal interference stimulation (tTIS) applied to the central medial-parafascicular (CM-pf) region in patients with disorders of consciousness, including those with severe brain injury, unresponsive wakefulness syndrome, and minimally conscious state. The study aims to explore how this device-based treatment may impact the recovery of consciousness in affected patients. Participants will receive tTIS treatment over the bilateral CM-pf once a day for 10 days. This intervention involves the use of a device designed to stimulate specific brain regions noninvasively, with no placebo or comparator group mentioned. The treatment period is limited to 10 consecutive days. During the study, researchers will assess changes in the Coma Recovery Scale-Revised (CRS-R) total score from enrollment to the end of the 10-day treatment. They will also monitor the number of patients showing improved consciousness and observe electroencephalogram (EEG) changes over the same period. The study includes adults aged 18 to 65 years and involves close monitoring throughout the treatment duration.
CONDITIONS
Brief Title
Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosis of vegetative state/unresponsive wakefulness syndrome or minimally conscious state due to traumatic or nontraumatic brain injury
- Diagnosed according to published diagnostic criteria
You will not qualify if you...
- Patients in coma with less than 1 week after acute brain injury
- Patients with fluctuating diagnosis on baseline assessment
- Patients with metallic cerebral implants or pacemakers
- Patients with epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive transcranial temporal interference stimulation (tTIS) applied over the bilateral CM-pf once a day for 10 days.
10 daily visits (in-person)
Trial Site Locations
Total: 2 locations
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
2
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
G
Gengyao Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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