idiopathic blepharospasm (iBSP)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Diagnosed as iBSP by 2 specialists according to the diagnostic criteria; (2) Age 18-70 years old; (3) Disease duration < 10 years; (4) Jankovic Rating Scale (JRS) frequency sub-scale score = 3 points; (5) Newly diagnosed patients who have not received any treatment and are unwilling to receive oral medications and invasive treatments such as botulinum toxin injections; (6) have received oral drug therapy in the past, but the therapeutic effect is not satisfied or the drug side effects are not tolerated and are unwilling to accept invasive treatment such as botulinum toxin injection; (7) All candidates signed informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Patients with family history or diagnosis of hereditary dystonia, acquired dystonia, tardive dyskinesia, or functional dyskinesia; (2) Patients with acute intracranial diseases (such as stroke, intracranial infection, etc.), or have a history of psychiatric diseases, dementia, epilepsy, multiple sclerosis, Tourette's disease, Parkinson's disease or Parkinson's syndrome, severe craniocerebral trauma and other neurological diseases; (3) Patients with severe systemic diseases that significantly shorten life expectancy; (4) Patients with obvious anxiety or depression, in which Hamilton Anxiety Scale (HAMA) -14 and/or Hamilton Depression Scale (HAMD) -17 scores are more than 14 points; (5) Patients with cognitive decline, in which Minimum Mental State Examination (MMSE) is less than 24 points; (6) Patients who are contraindicated for MRI examination by implanting metal or electronic devices such as cardiac pacemakers or artery clips in the body; (7) T2-weighted or Flair imaging found white matter signal abnormalities of grade 2 or above (grade 1 = scattered punctate lesions; Grade 2 = fusion lesions; Level 3 = large fusion area); (8) Participants in other clinical trials within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness in relieving motor symptoms when subjects received topical FEO for 3 months.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of motor symptom score after receiving topical frankincense essential oil;Improvement rate of subjects' quality of life after topical FEO;Subjective efficacy evaluation after topical FEO;Incidence of adverse reactions in subjects after topical FEO; | — |
Countries
China
Contacts
The First Affiliated Hospital of Sun Yat-sen University