Dystonia
Conditions
Interventions
Sponsors
Shanghai Children's Medical Center
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age: 3 - 18 years old, gender not restricted; 2. Meets the diagnostic criteria of the Chinese Neurology Society's "Chinese Expert Consensus on the Diagnosis of Dystonia"; 3. Has not achieved satisfactory results with drug treatment (such as at least two drugs still cause significant dystonia or are intolerable) or cannot tolerate the drugs, and has not accepted drug treatment and is not undergoing any other neuroregulation treatment at present; 4. Can cooperate to complete neuroregulation intervention and follow-up assessment; 5. Has signed the informed consent form (for >= 8-year-old participants, both the individual and the guardian need to sign; for < 8-year-old participants, the guardian only needs to sign).
Exclusion criteria
Exclusion criteria: 1. Prior history of deep brain stimulation (DBS) or other cranial surgery; 2. Presence of severe psychiatric or behavioral disorders (meeting internationally recognized diagnostic criteria, e.g., DSM-5 or ICD-10/11, and causing significant and persistent impairment in cognition, emotion, or behavior), making the participant unable to comply with the study; 3. Significant skin lesions, infection, allergy, or damage at the electrode placement site; 4. Participation in other interventional clinical studies involving drugs or medical devices within 1 month prior to enrollment; 5. Any condition that, in the investigator’s judgment, may compromise patient safety or affect the evaluation of efficacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate in severity of dystonia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate in gross motor function;Quality of life of children;Changes in self-harm frequency; | — |
Countries
China
Contacts
Public ContactXiaolai Ye
Shanghai Children's Medical Center
Outcome results
None listed