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

Phase 2

Completed

• Conditions: refractory vestibular dysfunction

• Registration Number: JPRN-jRCT1080224083
• Lead Sponsor: Department of Otolaryngology-Head and Neck Surgery, University of Tokyo Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-08
• Study Completion: 2022-05-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 50

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 < 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.

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>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.<br>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.<br>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.