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Research and transformation of wearable low-frequency pulse ultrasound in the treatment of paroxysmal kinesigenic dyskinesia

Research and transformation of wearable low-frequency pulse ultrasound in the treatment of paroxysmal kinesigenic dyskinesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078966
Enrollment
Unknown
Registered
2023-12-21
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paroxysmal kinesigenic dyskinesia

Interventions

Test Group - High:Ultrasound therapy (1.5 W/cm2)
Test Group - Medium:Ultrasound therapy (1.0 W/cm2)
Test Group - Low:Ultrasound therapy (0.5 W/cm2)
Control Group:No ultrasound therapy

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Meeting the diagnostic criteria for primary PKD: Consensus of Chinese experts in the diagnosis and treatment of paroxysmal kinesigenic dyskinesia; 2) = 14 years old and currently exhibiting clinical symptoms; 3) Patients who have not received anti-epileptic drug treatment within 3 months; 4) Cooperate with various examinations during clinical research; 5) Voluntary participation, with the consent of the patient and their family/guardian, and the signing of an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Secondary PKD caused by various factors, such as hyperthyroidism, encephalitis, multiple sclerosis, etc; 2) Patients with underlying diseases and other central nervous system diseases, such as stroke, history of trauma, history of brain tumors, etc. 3) Pregnant and lactating women; 4) Patients with pacemaker implantation; 5) Long term use of anticoagulants, antipsychotic drugs, and other neuropsychotic drugs; 6) Individuals with mental illness, depression, substance dependence, etc. 7) Patients who are unable to communicate with researchers or staff. 8) Simultaneously participating in other clinical researchers.

Design outcomes

Primary

MeasureTime frame
PKD severity score;

Secondary

MeasureTime frame
High density EEG;adverse event incidence rate;

Countries

China

Contacts

Public ContactLi Cao

Shanghai Sixth People's Hospital

caoli@rjlab.cn+86 134 7261 0202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026