Julien Engelhardt1, René Dauman2, Pierre Arné3, Michèle Allard4, Nicolas Dauman5, Olivier Branchard1, Paul Perez6, Christine Germain6, François Caire7, Damien Bonnard2, Emmanuel Cuny8. 1. CHU Bordeaux, Service de Neurochirurgie, France. 2. CHU Bordeaux, Service d'Oto-Rhino-Laryngologie, France; University of Bordeaux, France. 3. CHU Bordeaux, Service d'Exploration Fonctionnelle Neurologique, France. 4. University of Bordeaux, INCIA, UMR 5287 and CNRS, INCIA, UMR 5287, France. 5. University of Poitiers, CAPS-EA4050, Department of Psychology, France. 6. CHU Bordeaux, Unité de Soutien Méthodologique à la Recherche Clinique (USMR), Pôle de Santé Publique, France. 7. CHU Limoges Service de Neurochirurgie, and ERMA, Univ. Limoges, France. 8. CHU Bordeaux, Service de Neurochirurgie, France; University of Bordeaux, France. Electronic address: emmanuel.cuny@chu-bordeaux.fr.
Abstract
BACKGROUND:Chronic severe tinnitus can be greatly detrimental to quality of life. Some authors have reported benefit of repetitive transcranial magnetic stimulation, others of electrical cortical stimulation by stimulating the Heschl's gyrus or secondary auditory areas. OBJECTIVE: To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus. METHOD: In this double-blind randomized cross-over, patients with chronic (at least 2 years), severe (Strukturierte Tinnitus-Interview, STI score > 19), unilateral or strongly lateralized tinnitus were included. After open-phase stimulation for 4 months, patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between. Each of the 3 phases was 2 weeks in duration. Patients were chronically stimulated and followed if not explanted. A decrease of STI score >35% was considered as clinically significant. RESULTS: None of the 9 patients included achieved significant improvement during the double-blind phase. Four were explanted, 2 owing to lack of effect, one for breast cancer under the stimulator, and another for psychiatric decompensation. Five are still stimulated. Three felt slight to great subjective effectiveness, the remaining 2 reported benefits and still requested stimulation. CONCLUSIONS: This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus. The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery, but may also be explained by a poorly defined target, a too short randomized phase, or inappropriate outcome measures. Clinical trial reference: NCT00486577.
RCT Entities:
BACKGROUND: Chronic severe tinnitus can be greatly detrimental to quality of life. Some authors have reported benefit of repetitive transcranial magnetic stimulation, others of electrical cortical stimulation by stimulating the Heschl's gyrus or secondary auditory areas. OBJECTIVE: To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus. METHOD: In this double-blind randomized cross-over, patients with chronic (at least 2 years), severe (Strukturierte Tinnitus-Interview, STI score > 19), unilateral or strongly lateralized tinnitus were included. After open-phase stimulation for 4 months, patients were randomized into 2 groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between. Each of the 3 phases was 2 weeks in duration. Patients were chronically stimulated and followed if not explanted. A decrease of STI score >35% was considered as clinically significant. RESULTS: None of the 9 patients included achieved significant improvement during the double-blind phase. Four were explanted, 2 owing to lack of effect, one for breast cancer under the stimulator, and another for psychiatric decompensation. Five are still stimulated. Three felt slight to great subjective effectiveness, the remaining 2 reported benefits and still requested stimulation. CONCLUSIONS: This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus. The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery, but may also be explained by a poorly defined target, a too short randomized phase, or inappropriate outcome measures. Clinical trial reference: NCT00486577.
Authors: Martin Formánek; Petra Migaľová; Petra Krulová; Michal Bar; Debora Jančatová; Hana Zakopčanová-Srovnalová; Hana Tomášková; Karol Zeleník; Pavel Komínek Journal: Ann Clin Transl Neurol Date: 2018-06-08 Impact factor: 4.511