Trials / Completed
CompletedNCT03500718
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Jawaharlal Institute of Postgraduate Medical Education & Research · Other Government
- Sex
- All
- Age
- 1 Year – 6 Years
- Healthy volunteers
- Accepted
Summary
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.
Detailed description
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cochlear implant | After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP). |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-04-18
- Last updated
- 2020-02-24
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03500718. Inclusion in this directory is not an endorsement.