A Phase 2/3 interventional study of significant chronic primary auditory cortex stimulation during the first two weeks and non significant chronic primary auditory cortex stimulation during the first two weeks in Hearing Disorders, Hearing Loss and Hyperacusis, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-01-28.
Sponsored by University Hospital, Bordeaux · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine whether chronic electrical stimulation of the primary auditory cortex is effective in the treatment of chronic, severe and intractable tinnitus
Severe and chronic tinnitus - the perception of sound in one or both ears or in the head when non-external sound is present - can be disabling and difficult to treat. Physiopathology of tinnitus can be considered as similar to neuropathic pain. Neuropathic and central pain are treated since ten years by chronic electrical motor cortex stimulation. The hypothesis of this study is that it will be possible to treat severe tinnitus by this stimulation as neuropathic pains are treated by motor cortical stimulation.
Patient >18 years of age and \< 70 years of age Permanent and chronic tinnitus during more than 2 years. A score over 19 at the STI (Quality of life index for tinnitus) Unilateral tinnitus
65 studies on the registry are indexed under Hearing Disorders; 17 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 45 interventional studies indexed under Hearing Disorders.
Browse Hearing Disorders studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: significant chronic primary auditory cortex stimulation during the first two weeks
Procedure: non significant chronic primary auditory cortex stimulation during the first two weeks
significant chronic primary auditory cortex stimulation during the first two weeks of the follow up than wash out period followed by two weeks of non significant stimulation
non significant stimulation during the first two weeks of the follow up than wash out period followed by two weeks of significant chronic primary auditory cortex stimulation
intensity of the tinnitus. The cut off efficacy is 35% improvement on the STI score
Time frame: 6 months
Tinnitus Handicap Questionnaire Multiple Activity Scale for Hyperacusis questionnaires for assessment of the patients and treatment outcome of tinnitus hyperacusis and loss of hearing subjective global improvement scale
Time frame: 6 months
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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