Post-burn itch
Conditions
Interventions
Phase II: Sham Stimulation Group:A non-invasive cranial nerve stimulator (NervioX-1000) was used for sham stimulation.
Phase I: Non-itch burn group:None
Phase II: TI Stimulation Group:TI stimulation was performed with a non-invasive cranial nerve stimulator (NervioX-1000).
Phase I: Healthy control group (healthy volunteers):None
Phase I: Burn itch group:None
Sponsors
The First Affiliated Hospital of Army Medical University PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Phase I: 1. Patients voluntarily participate in this study and sign the informed consent form. 2. Age between 18 and 60 years old, with no gender restriction. 3. Burn patients: those with burn wounds healed over 90% or more than 4 weeks after the last skin grafting, or the presence of burn scars; 4. Healthy volunteers: volunteers without any organic or functional disorders in any organ, matched with burn patients in terms of gender, age, and educational level; 5. Possessing a certain level of listening, speaking, reading, writing, and comprehension abilities, capable of independently completing the study questionnaire. Phase II : 1. Patients must voluntarily participate in this study and sign the informed consent form. 2. Age must be between 18 and 60 years, with no gender restriction. 3. Clinical diagnosis must confirm the presence of severe itching (WINRS score =7) caused by burn wounds (more than 90% healed or at least 4 weeks after the last skin grafting) or burn scars, persisting for 4 weeks or longer. 4. Conventional treatment (oral administration of antihistamines or psychotropic drugs for more than 4 weeks) must have been ineffective (WINRS score >=7) or intolerable. 5. There must be no injuries such as wounds on the scalp. 6. No use of psychotropic medications in the past 4 weeks. 7. Patients must pass the adult TI safety screening questionnaire. 8. Patients must demonstrate adequate listening, speaking, reading, and comprehension abilities to independently complete the study scales.
Exclusion criteria
Exclusion criteria: Phase I: 1.Any contraindications for MRI scanning; 2. Itching caused by other skin lesions (eczema, dermatitis, allergies, infections, etc.), internal diseases (diabetes, long-term dialysis, etc.); 3. Pregnant, breastfeeding, or planning to become pregnant during the trial. Phase II : 1. History of mental, neurological disorders such as cognitive dysfunction, and history of drug abuse; 2. Itching caused by other skin lesions (eczema, dermatitis, allergies, infections, etc.), internal diseases (diabetes, long-term dialysis, etc.); 3. Presence of intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants or electrodes) or any other metal objects inside or near the head, cardiac pacemakers, metal internal fixtures, etc.; 4. Currently undergoing other neuromodulation techniques (transcranial magnetic stimulation therapy, noninvasive transcutaneous neural stimulation, transcranial electrical stimulation therapy, etc.) or medications (systemic or topical use of glucocorticoids, etc.) that may interfere with TI; 5. Pregnant, breastfeeding, or planning to become pregnant during the trial; 6. History of epileptic seizures or previous presence of epileptic convulsions; 7.Unstable vital signs; 8. Any other contraindications for MRI scanning; 9.Currently participating in other clinical interventional trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: Neuroimaging markers;Phase II: 7-day itching improvement rate;Phase 1: High-resolution structure (T1 MP-2RAGE);Phase I: white matter fiber bundles in the brain;Phase I: Resting-state BOLD functional imaging;Phase I: MRS spectroscopy;Phase I: Endogenous metabolites and biomarkers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Quality of life;Phase II: Incidence of adverse events;Phase II: Cognitive impairment;Phase II: Scar function parameters;Phase II: Improvement of sleep disorder;Phase II: Changes of the lSS and NRS score;Phase II: Scar severity;Phase II: Change of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS ) score; | — |
Countries
China
Contacts
Public ContactHaisheng Li
The First Affiliated Hospital of Army Medical University PLA
Outcome results
None listed