Vestibular rehabilitation with nGVS for PPPD

JRCT ID: jRCTs042240022

Registered date:30/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Persistent postural-perceptual dizziness
• Date of first enrollment: 30/04/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Control group: Vestibular rehabilitation (VR) under the supervision of a physical therapist (PT) once a week for 30 minutes. Home VR for 15 minutes twice daily. For 8 weeks.
Treatment group: Control group treatment + noisy galvanic vestibular stimulation (nGVS) during VR under the supervision of a PT

Outcome(s)

• Primary Outcome: Change in DHI scores at pre and 1 months after treatment

Secondary Outcome

#total score of DHI
#DHI remission rate (14 points or less) and response rate (improvement of 18 points or more)
#physical, emotional, functional subscales of DHI
#Vertigo Symptom Scale-short form (VSS-sf)
#Niigata PPPD Questionnaire (NPQ)
#Hospital Anxiety Depression Scale (HADS)
#The Patient Global Impression scale (PGI)
#Total length of posturography (eye open, eye closed, rubber eye open, rubber eye closed)
#TUG Test, Functional Gait Assessment (FGA), Motion Sensitivity Quotient (MSQ)
#Visual Analogue Scale about dizziness
#Home rehabilitation adherence
#adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1.Persistent postural-perceptual dizziness
2.Dizziness Handicap Inventory (DHI) >= 36
3.Hospital Anxiety Depression Scale, subscale of anxiety<=10, subscale of depression<= 10
4.Not planning to change to medications that affect dizziness
5.between the ages of 20 and 80
6. Written informed consent

Exclude criteria

1. with metal in the body, such as cerebral artery clips or pacemakers
2. orthopedic conditions (especially acute painful conditions such as fractures, sprains, and separated flesh)
3. with heart disease
4. unable to walk independently
5. malignant tumor
6. pregnancy and immediately after delivery
7. sensory disturbance due to severe peripheral circulatory disturbance caused by diabetes mellitus, etc.
8. skin abnormality (infection, wound, etc.) at the electrode application site, or skin allergy to surface electrodes
9. psychiatric symptoms that are considered uncontrollable even with appropriate treatment such as medication
10. other patients who are judged to be inappropriate as subjects

Related Information

• Primary Sponsor: Kabaya Kayoko