Primary Focal Dystonia
Conditions
Interventions
Intervention group1:Subjects will first receive 10 days of temporal interference (TI) stimulation, once daily for 30 minutes per session. Following a 2-week washout period, subjects will receive 10 da
Intervention group 2:Subjects will first receive 10 days of sham stimulation, once daily for 30 minutes per session. Following a 2-week washout period, subjects will receive 10 days of temporal interf
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, regardless of gender. 2. Clearly diagnosed with Primary focal dystonia. 3. BoNT naïve or at least a 3 months interval between last BoNT injection. 4. Voluntarily signs the informed consent form, understands and accepts the study duration, and is able and willing to comply with all requirements, including scheduled treatments, follow-ups, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Secondary dystonia (e.g., drug-induced, metabolic, vascular, or structural lesions) 2. combined dystonia (i.e., coexisting with other clinically significant movement disorders like PD or ET), or concurrent cognitive impairment due to other causes. 3. Dystonia symptoms significantly worsening or improving within 4 months prior to screening. 4. Change in anti-dystonia medication dosage within the last 4 months prior to screening. 5. Any ferromagnetic metallic implants, electronic devices (e.g., DBS, VNS, pacemakers) intracranially or circumferentially. 6. Severe skin diseases, broken skin, scarring, or burns in the intended electrode placement area on the scalp or face. 7. Any MRI contraindications, including claustrophobia. 8. History of DBS surgery, or receipt of any other neuromodulation treatments (e.g., tDCS, rTMS, FUS) within 6 months prior to screening. 9. Severe or unstable cardiovascular, hepatic, renal, respiratory, endocrine, immune, or hematological diseases, or any condition that the investigator deems harmful or interfering with the study. 10. History of cancer within the last 5 years (excluding non-metastatic low-risk cancers), or expected lifespan of < 24 months. 11. History of primary psychiatric illness (schizophrenia, chronic psychosis) or current significant suicide risk/active suicidal ideation. 12. severe drug/treatment hypersensitivity reaction history 13. History of alcoholism or drug abuse within 2 years prior to screening. 14. Subjects currently participating in other interventional clinical trials. 15. Female subjects who are pregnant or planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Burke-Fahn-Marsden Dystonia Rating Scale- Movement Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blepharospasm disability index;Oromandibular Dystonia Rating Scale;Toronto Western Spasmodic Torticollis Rating Scale;Montreal Cognitive Assessment;Minimum Mental State Examination;Hamilton Rating Scale for Anxiety;Hamilton Rating Scale for Depression;36-Item Short Form Survey; | — |
Countries
China
Contacts
Public ContactXin Chen
Tianjin Medical University General Hospital
Outcome results
None listed