Actively Recruiting
Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
Led by Huashan Hospital · Updated on 2025-12-16
20
Participants Needed
2
Research Sites
55 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
S
Shanghai First Rehabilitation Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.
CONDITIONS
Official Title
Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender
- Diagnosis of minimally conscious state or vegetative state lasting 28 days or more
- Normal body temperature, stable vital signs, spontaneous breathing
- Tracheotomy patients without metal cannula and with small sputum amount
- Eligible for magnetic resonance imaging (MRI) examination
- Written informed consent from patient's family obtained in advance
You will not qualify if you...
- History of major neuropsychiatric disorders or significant heart, lung, liver, kidney diseases
- Previous or planned V-P shunt or Ommaya reservoir implantation
- Pregnant women
- Participation in other drug or device clinical trials
- Poorly controlled epilepsy recently
- Infection or damaged skin at stimulation site
- Taking medications prone to cause epilepsy (e.g., quinolone drugs)
- Intracranial infections, tumors, or metallic objects in the skull
- Allergy to electrode gel or adhesives
- Implanted electronic devices in the body
- Severe cardiac disorders or having cardiac pacemakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of neurological rehabilitation, Shanghai First Rehabilitation Hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
X
Xuehai Wu, Ph.D.
CONTACT
W
Wentao Huang, M.M.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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