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Prospective study on the efficacy of botulinum toxin A injection and deep brain stimulation in the treatment of primary Meige syndrome

Prospective study on the efficacy of botulinum toxin A injection and deep brain stimulation in the treatment of primary Meige syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-17013806
Enrollment
Unknown
Registered
2017-12-10
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

Primary Meige syndrome

Interventions

control group:Botulinum toxin type A injection

Sponsors

Bei Jing Tong Ren hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with primary Meige syndrome; 2. Patients who have failed to effectively control symptoms and seriously affect quality of life through botulinum A toxin treatment; 3. Good health conditions except the symptoms of dystonia; 4. The results of the simple mental state scale (MMSE) screening were normal; 5. The subjects or their families can fully understand the therapy and sign the informed consent; 6. The subjects have good compliance and can cooperate with the follow-up requirements after the operation.

Exclusion criteria

Exclusion criteria: 1. Imaging examination of patients with abnormal changes in the basal ganglia; 2. Patients had a serious progressive nervous system, a cardiovascular system, a respiratory system, or a digestive system disease; the patient's mental state is unstable; 3. Patients have surgical or anesthetic contraindications, such as long-term anticoagulant, antiplatelet drugs, etc; 4. Women who are planning to be pregnant, or are in pregnancy and breast-feeding; 5. Patients had or needs other implants, such as the cardiac pacemaker, defibrillator, cochlear, and the root electric stimulator; 6. Patients need multiple 3.0T MRI tests during future clinical trials for their own reasons; 7. Patient had taken part in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Burke-Fahn-Marsden DystoniaRating Scale;

Secondary

MeasureTime frame
Adverse reaction and Quality of life scale;HAMA and HAMD Scale;

Countries

China

Contacts

Public ContactFu Jing

Bei Jing Tong Ren hospital, Capital Medical University

fu_jing@126.com+86 13801218591

Outcome results

None listed

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