臨床研究等提出・公開システム

double-blind randomized placebo-controlled cross over clinical trial to confirm the safety and the effectiveness of noisy galvanic vestibular stimulation to improve postural stability in patients with refractory vestibular dysfunction with severe postural instability

Clinical trial of noisy galvanic vestibular stimulation to improve postural stability in patients with refractory vestibular dysfunction

No

University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

iwashin-tky@umin.ac.jp

University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

+81-3-5800-8665

iwashin-tky@umin.ac.jp

completed

Feb. 06, 2019

Interventional

This is a double-blind randomized placebo-controlled cross over clinical trial. Subjects who provide their informed consent and are confirmed to be eligible will be provisionally enrolled. Among them, only the subjects confirmed to have optimal stimulation in its examination will be enrolled. Subjects who have no optimal stimulation will be excluded from the trial at this point and safety is confirmed 2 weeks later. The enrolled subjects will be randomly allocated to two groups. One group will be first evaluated for the effect of noisy GVS for 4-h stimulation, then the placebo stimulation 2 weeks later, as well as the effect of repetitive stimulation. The other group will be evaluated for the effect of placebo stimulation, then the effect of noisy GVS for 4-h stimulation. These 2 groups were allocated 1:1 ratio randomly. The enrollment and the first visit is at least 7 days apart.

treatment purpose

2-3

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 < 10 deg/sec.
2) The total path length of center of pressure is > 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.

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)

Both

refractory vestibular dysfunction

investigational material(s)
Generic name etc : Portal stimulator for noisy galvanic vestibular stimulation
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Noisy galvanic vestibular stimulation is delivered through surface electrodes on the mastoids. The intensity of stimulation is the one which reduce the sway path length of stabilometer most and is below the sensation threshold between 100 and 2000 microA.

control material(s)
Generic name etc : Portal stimulator for noisy galvanic vestibular stimulation
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Noisy galvanic vestibular stimulation is delivered through surface electrodes on the mastoids. The intensity of stimulation is the one which reduce the sway path length of stabilometer most and is below the sensation threshold between 100 and 2000 microA.

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.

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.

+81-3-5841-0818

Dec. 17, 2018