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Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)

NCT04296097 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-12-16

No results posted yet for this study

Summary

This pilot study aims at evaluating the effectiveness of the treatment of unilateral or bilateral, non-pulsatile, disabling, tinnitus, without vestibular dysfunction, using Deep Brain Stimulation (DBS) of the parieto-insular right operculum 3 (OP3) in a cross-over, double study design.

Conditions

  • Severe Permanent Uni or Bilateral Non-pulsatile Tinnitus
  • Without Associated Vestibular Pathology
  • Resistant to Therapeutic Failure
  • With or Without Hearing Loss

Interventions

DEVICE

DBS

Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)

Sponsors & Collaborators

  • Commissariat A L'energie Atomique

    collaborator OTHER_GOV

  • Équipe 5 Neuroimagerie et perfusion cérébrale, Grenoble Institut des Neurosciences (GIN)

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • France

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 NCT04296097 on ClinicalTrials.gov