NCT06782308

Brief Summary

The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation). This survey covers the acceptance of a surgically-placed brain implant, of its associated risks related to the neurosurgical procedure, usability considerations, and the willingness/ability to pay for such a treatment. Neurosoft Bioelectronics will use the collected patients' feedback and usability preferences data for the development of a novel minimally invasive brain implant aimed at alleviating tinnitus.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

January 13, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

January 13, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

tinnitusiBCIbrain implantsurveyrisks acceptanceuser preferencespatient preferencessubjective tinnituschronic tinnitussevere tinnituscatastrophic tinnitusinvasive neuromodulationsurgical treatment

Outcome Measures

Primary Outcomes (1)

  • Acceptance of invasive neuromodulation treatments for chronic tinnitus

    Risks acceptance and user preferences will be assessed through responses to the survey. The outcome will be summarized in the form of a percentage or similar statistics on acceptances rates for surgical interventions in patients with chronic tinnitus. Acceptance rates will also be evaluated in accordance to several clinical characteristics of tinnitus, such as its perceived annoyance or loudness.

    1 year

Secondary Outcomes (2)

  • Usability preferences for implantable neuromodulation systems for chronic tinnitus

    1 year

  • Willingness and ability to pay for novel invasive neuromodulation solutions for chronic tinnitus

    1 year

Study Arms (1)

patients with tinnitus

Other: Survey using a questionnaire.

Interventions

patients preferences survey

patients with tinnitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (over 18 years old) with chronic, subjective severe tinnitus

You may qualify if:

  • Individuals aged 18 or older suffering from subjective tinnitus
  • Self-reported or healthcare professional-diagnosed chronic (lasting 3 months or longer), subjective, burdensome tinnitus

You may not qualify if:

  • Individuals under 18 years of age
  • Healthy volunteers without tinnitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosoft Bielectronics US Inc.

New York, New York, 10016, United States

RECRUITING

Related Links

MeSH Terms

Conditions

TinnitusHearing LossPatient Preference

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Nicolas Gninenko, PhD

    Neurosoft Bioelectronics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Gninenko, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Neuroscientist

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 17, 2025

Study Start

January 13, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations