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A prospective cohort study on the efficacy of auditory brainstem implant and changes in cortical plasticity in patients with congenital deafness at different ages

A prospective cohort study on the efficacy of auditory brainstem implant and changes in cortical plasticity in patients with congenital deafness at different ages

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036429
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

congenital deafness

Interventions

A:ABI
B:ABi
C:ABI

Sponsors

Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Children with congenital deafness; 2) Aged between 1 and 6 years old; 3) Imaging diagnosis is one of the following conditions: immature inner ear (Michel malformation), cochlea aplasia or dysplasia, rudimentary otocyst, cochlear nerve aplasia or dysplasia; 4) Audiological examination diagnosed as bilateral profound or severe sensorineural hearing loss; 5) Evaluation by the Hearing Center of our hospital is not suitable for cochlear implantation.

Exclusion criteria

Exclusion criteria: 1) Children with acquired deafness; 2) Children who have undergone cochlear implant surgery; 3) Children and their families who cannot cooperate with regular follow-up after operation; 4) Severe central nervous system diseases such as white matter dysplasia and epilepsy; 5) General anesthesia is not suitable for basic diseases; 6) Children with malignant tumors, pneumonia, upper respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
MESP;CAEP;fMRI;

Secondary

MeasureTime frame
PTA;CAP;gesell;EABR;

Countries

China

Contacts

Public ContactZhang Zhihua

Department of Otolaryngology, Head & Neck Surgery, Shanghai Ninth People’s Hospital, affiliated to Shanghai Jiaotong University School of Medicine

zhihua.zhang2015@aliyun.com+86 13761638443

Outcome results

None listed

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