refractory vestibular dysfunction
Conditions
Interventions
investigational material(s)
Generic name etc : Portal stimulator for noisy galvanic vestibular stimulation
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administr
Sponsors
Department of Otolaryngology-Head and Neck Surgery, University of Tokyo Hospital
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) unilateral or bilateral vestibular dysfunction as revealed by caloric test Unilateral vestibular dysfunction is defined as CP (Canal paresis) = (Maximal slow phase velocity (MSPV) of the healthy ear - MSPV of the diseased ear)/ (MSPV of healthy ear + MSPV of diseased ear)x 100 > 20%. Bilateral vestibular dysfunction is defined as MSPV of both ears 180 cm/ 60 s during two legged stance with eyes-closed condition 3) Dizziness continue > 1 y, vestibular rehabilitation > 6 m. 4) Age between 20 y and 85 y 5) Participants must understand the content of the trial and agree with the participation by their own will.
Exclusion criteria
Exclusion criteria: 1)Metal in the body, including intracephalic aneurysm clips and pace makers 2)Orthopedic disease 3)Motor dysfunction caused cerebellar or spinal disease 4)Heart disease 5)A malignant tumor 6)Acute infection 7)Pregnant or just after delivery 8)Inability to walk without assistance 9)Skin abnormality on mastoids 10)Medicated by any tranquilizers and/or antidepressants 11)Consumed alcohol after 10 PM the day prior to the trial 12)Deemed not eligible by the investigator (co-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Changes from the baseline in the total path length measured by the stabilometer (Anima, GW-6000 or GP-6000) at 0 h, 0.5 h, 1 h, 2 h, and 3 h after the onset of the stimulus. 1)Descriptive statistics are calculated for the value and the changes in the total path length at all measurement points in each group. Then those values are calculated in the combined group. Those values are also calculated in each subject and compared using t-test. 2)The averaged value of the changes in the total path length from just after the start of noisy GVS to 3-h after the start and those value of placebo stimulus are compared using paired t-test. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Evaluation of the effectiveness 1.Changes from the baseline in the envelopment area and the RMS (root mean square) of the center of pressure measured by the stabilometer (Anima, GW-6000 or GP-6000) at 0 h, 0.5 h, 1 h, 2 h, and 3 h after the onset of the stimulus. 2.Changes in the total path length, the envelopment area and the RMS of COP measured at 4 h, 5 h, 6 h, and 7 h from the onset of the stimulus. 3.Gait function Changes in the following parameters measured at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h after the onset of the stimulus.: Dynamic Gait Index (DGI short version) score Velocity, step length, step time and the distance of X-axis during 10 m walk measured by Walk Analyzer (Walk Mate Viewer; WALK MATE LAB Inc.). 4.Subjective improvement score Changes in the following parameters measured at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h after the onset of the stimulus.: Subjects compared their condition by the 5 degrees: 1: improvement, 2: slight improvement, 3: no change, 4: slightly worse, 5: worse 5.Quality of Life (QOL) QOL is evaluated at 3 h and 7 h after the onset of the stimulus using modified Fall Efficacy Scale (mFES) and Dizziness Handicap Inventory (DHI). 6.Activity Activity is measured at 3 h and 7 h after the onset of the stimulus using and activity analyzer. Evaluation of the safety Adverse events and malfunction are evaluated. | — |
Countries
Japan
Outcome results
None listed