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Intelligent guided injection of botulinum toxin A using ultrasound imaging for the treatment of salivation in Parkinson's disease patients

Intelligent guided injection of botulinum toxin A using ultrasound imaging for the treatment of salivation in Parkinson's disease patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077920
Enrollment
Unknown
Registered
2023-11-23
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Parkinson’s disease

Interventions

Low dose group:Under ultrasound guidance, BXT-A was injected into four salivary glands of each patient, including bilateral submandibular glands and bilateral parotid glands. Each gland was injected w
High dose group:Under ultrasound guidance, BXT-A was injected into four salivary glands of each patient, including bilateral submandibular glands and bilateral parotid glands. Each gland was injected
Healthy control group:Take no intervention measures

Sponsors

Nanjing Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the latest diagnostic criteria for Parkinson's disease published by the International Association for Movement Disorders (MDS) in 2015, and should be accompanied by salivation; The healthy control group must exclude other neurological diseases; (2) Body weight: BMI index within the range of 18-30; (3) Discontinue drugs that may exacerbate salivation, such as antipsychotic drugs (clozapine or quetiapine) and cholinesterase inhibitors, and optimizing dopamine therapy; (4) Age>18 years old, with basic normal cognition, can voluntarily cooperate with botulinum toxin injection treatment; (5) All enrolled patients are required to sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Unstimulated salivary flow rate<0.20ml/min; (2) Oral diseases caused by fungi, bacteria, or viruses, such as oral ulcers, gingivitis, etc; (3) Take acetylcholine receptor inhibitors, probiotics, or antibiotics within one month before enrollment; (4) Exclude other motor disorders such as secondary Parkinson's syndrome, progressive supranuclear palsy, and primary hepatolenticular degeneration; (5) Use botulinum toxin for treatment within the past 4 months. (6) The researchers believe that it is not suitable for participants in this clinical study.

Design outcomes

Primary

MeasureTime frame
Salivation related scale for Parkinson's disease;salivary related parameters;microbial related parameters in saliva;

Secondary

MeasureTime frame
Treatment (drugs, rehabilitation, acupuncture and moxibustion and psychotherapy);The efficacy and adverse reactions of different treatment methods;

Countries

China

Contacts

Public ContactJun Yan

Nanjing Brain Hospital

yanjun2008@njmu.edu.cn+86 138 1385 0272

Outcome results

None listed

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