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Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

NCT03530306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2024-12-20

No results posted yet for this study

Summary

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

Conditions

  • Tinnitus

Interventions

DEVICE

PS1-PS4

Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

DEVICE

PS6-PS10

Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

DEVICE

PS7-PS4

Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

DEVICE

PS9-PS6

Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.

Sponsors & Collaborators

  • Neuromod Devices Ltd.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2018-10-02
Completion
2019-07-18

Countries

  • Ireland

Study Locations

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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 NCT03530306 on ClinicalTrials.gov