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Analyses of the equilibrium and cortical function after use of TPAD

Phase 1
Recruiting
Conditions
chronic vertigo
Registration Number
JPRN-jRCTs042190060
Lead Sponsor
Takakura Hiromasa
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

1. A study for healthy adults
A healthy adult
1) over 20 years old,
2) who have a sufficient ability to implement the operation smoothly
3) who provided the informed consent based on the free will
2. A study for the patient with chronic vertigo
A patient of chronic vertigo
1)who have a vertiginous sensation or a disequilibrium continuing more than three months
2)who have a sufficient ability to implement the operation smoothly
3) who provided the informed consent based on the free will

Exclusion Criteria

1. A study for healthy adults
The person
1)who does not provide the informed consent,
2)who is over 75 year old ,
3)who have had the operation of middle or inner ear, neurosurgical or orthopedic operation in the past
4) who have had psychiatric disorder in the past
5)who have the canal paralysis on caloric test or video head impulse test
6)who have taken the drug with inner ear toxicity, such as antituberculous agent, in a certain period
7) who have had some traumatic injury of head, four limbs or body in the past,
8)whom doctor judged not to be able to come to our hospital or to go back home safely after the test
9)who is or might be pregnant, or hope for the pregnancy during the study period, or does not use appropriate sterilization
10)whom the doctor judged to be in adequate as a subject
2. A study for the patient with chronic vertigo
The patient
1) who does not provide the informed consent
2)who want to stop the treatment
3)who stopped the treatment by oneself
4)who cannot continue to write a diary of vertigo
5)who cannot continue to do TPAD rehabilitation
6)whom the doctor judged not to be able to come to our hospital or to go back home safely after the test
7)who is or might be pregnant, or hope for the pregnancy during the study period, or does not use appropriate sterilization
8)whom the doctor judged to be in adequate as a subject

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1 A study for healthy adults<br> Data of stabilometry (outer peripheral area, locus length per unit area, Romberg ratio)<br>2 A study for the patient with chronic vertigo<br> Value of dizziness handicap inventory at 12 weeks later from the onset of TPAD rehabilitation
Secondary Outcome Measures
NameTimeMethod
Hemodynamic response recorded with Near-infrared spectroscopy(NIRS)
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