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A prospective, randomized controlled study of the efficacy and safety of the vagal stimulation system in treatment of Rett syndrome

A prospective, randomized controlled study of the efficacy and safety of the vagal stimulation system in treatment of Rett syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011793
Enrollment
Unknown
Registered
2017-06-28
Start date
2017-07-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Rett syndrome

Interventions

intervention:VNS treatment
control:fake treatment of VNS

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. aged 3-6 years old; 2. meet the diagnostic criteria for Rett syndrome; 3. with the use of vagus nerve stimulator treatment indications; 4. subjects and their families can fully understand the therapy and the signing of informed consent; 5. subjects and their families can complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. surgical and anesthesia practitioners identified contraindications for surgery, including cancer, arrhythmia, heart failure, progressive neurological diseases, asthma, mental illness, peptic ulcer, insulin-dependent diabetes mellitus or poor physical condition; 2. side or bilateral vagus nerve lesions or damage; 3. at the same time undergoing other drugs or equipment clinical trials; 4. preoperative examination is incomplete; 5. patients who is infection in the 7 days before surgery to the day of surgery.

Design outcomes

Primary

MeasureTime frame
Clinical Severity Scale;Clinical Global Impression Scale;Gesell Developmental Scale;128 Channel EEG;Eyetracking;

Secondary

MeasureTime frame
electrocardiogram;

Countries

China

Contacts

Public ContactLi-Ping Zou

The Paediatrics Center of PLA General Hospital

zouliping21@sina.com+86 010 66939770

Outcome results

None listed

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