Effects and safety of TPAD (Tilt Perception Adjustment Device) on symptom of vertigo and body sway in patients with vertigo: a phase 2 study

JRCT ID: jRCTs062180050

Registered date:14/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Vertigo
• Date of first enrollment: 03/02/2016
• Target sample size: 20
• Countries of recruitment: Non,Japan
• Study type: Interventional
• Intervention(s): Vibrotactile stimulation on mandible with TPAD (Tilt Perception Adjustment Device) in response to head tilt

Outcome(s)

• Primary Outcome: Changes in symptom of vertigo evaluated with VAS (Visual Analog Scale) or DHI (Dizziness Handicap Inventory) and body and gait sway evaluated with stabilometer, stabilometer with rubber or motion capture system
• Secondary Outcome: Adverse reaction such as pain or discomfort caused by TPAD

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1) male and female between the age of 20 and 65 years
2) Adult patients with vertigo

Exclude criteria

1) Patients with serious complications
2) Patients who was excluded by investigators

Related Information

• Primary Sponsor: Kitamura Yoshiaki
• Source(s) of Monetary Support: Japan Agency of Medical Research and development
• Secondary ID(s): Nil known