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A prospective study on the efficacy and safety of STN-DBS compared to GPi-DBS in the treatment of Meige syndrome

A prospective study on the efficacy and safety of STN-DBS compared to GPi-DBS in the treatment of Meige syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093942
Enrollment
Unknown
Registered
2024-12-13
Start date
2023-10-07
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Meige syndrome

Interventions

Group A:Using the STN target for deep brain stimulation therapy
Group B:Using the GPi target for deep brain stimulation therapy.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years; (2) Meeting the international diagnostic criteria for Meige syndrome; (3) Previously treated with oral medications and botulinum toxin injections with unsatisfactory results; (4) Disease duration >= 1 year; (5) Normal cognitive function, MMSE >= 24; (6) The subject or their legal representative is able to sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Females known to be pregnant or lactating, or have a positive pregnancy test before randomization; (2) dystonia caused by other secondary factors (including birth trauma, traumatic brain injury and psychiatric treatment, etc.); (3) refractory hypertension (defined as sustained systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) that is refractory to drug control ( Note: If the use of drugs can successfully lower blood pressure and maintain it at an acceptable level, it can be included in the study); (4) contraindications to MRI scanning (e.g., claustrophobia); (5) Patients with a history of previous brain surgery; (6) Major depression (HDRS>35) (7) Undergoing hemodialysis or peritoneal dialysis; Known severe renal insufficiency (glomerular filtration rate220 mmol/L (2.5 mg/dl)); (8) Contraindications to neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, sequelae of cerebrovascular disease, etc.; (9) Concomitant other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.); (10) have participated in other interventional clinical studies that may have an impact on outcome assessment; or other conditions that, in the opinion of the investigator, are not suitable for participation in this study or may pose a significant risk to the patient (such as inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional disorders).

Design outcomes

Primary

MeasureTime frame
Burke-Fahn-Marsden Dystonia Rating Scale;Unified Dyskinesia Rating Scale;Resting-state functional magnetic resonance imaging ;

Secondary

MeasureTime frame
Mini Mental State Scale;Montreal Cognitive Assessment;Hamilton Depression Scale;Hamilton Anxiety Scale;36-Item Short Form Survey;

Countries

China

Contacts

Public ContactHong Tian

China-Japan Friendship Hospital

tianhong5185@126.com+86 139 1177 3998

Outcome results

None listed

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