MedTrace Logo

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

NCT02669069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-12-20

No results posted yet for this study

Summary

This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Conditions

  • Tinnitus

Interventions

DEVICE

PS1

Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones.

DEVICE

PS2

Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.

DEVICE

PS3

Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.

Sponsors & Collaborators

  • University Hospital Regensburg

    collaborator OTHER

  • Neuromod Devices Ltd.

    lead INDUSTRY

Principal Investigators

  • Mr. Brendan Conlon · St. James's Hospital, Ireland

  • Prof. Dr. med. Berthold Langguth · University of Regensburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-27
Primary Completion
2017-07-31
Completion
2019-01-30

Countries

  • Germany
  • Ireland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669069 on ClinicalTrials.gov