Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3

NACompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

March 21, 2022

Primary Completion Date

September 6, 2022

Study Completion Date

October 25, 2022

Conditions
Tinnitus
Interventions
DEVICE

Lenire

The sound stimulus of PS6 is comprised of sequences of tones and is spectrally modified according to the participant's hearing thresholds so that different components of the sound stimulus can be sufficiently heard by the participant irrespective of their hearing characteristics (audiological profile). The tongue stimulus of PS6 is delivered by an array of electrical signals via 32 transmucosal electrodes contacting the anterodorsal surface of the tongue. The sound and tongue stimulus parameters are presented with certain stimulus rates and timing relationships between modalities.

Trial Locations (3)

9000

BRAI3N, Ghent

30625

German Hearing Center, Hanover

D08NHY1

The Wellcome HRB Clinical Research Facility at St. James's Hospital, Dublin

Sponsors
All Listed Sponsors
collaborator

BRAI3N (clinical site), Belgium

UNKNOWN

collaborator

St James's Hospital (clinical site), Ireland

UNKNOWN

collaborator

German Hearing Center Hannover (clinical site), Germany

UNKNOWN

collaborator

Avania (CRO/project manager), Netherlands

UNKNOWN

lead

Neuromod Devices Ltd.

INDUSTRY

NCT05227365 - Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 | Biotech Hunter | Biotech Hunter