UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062995 |
|---|---|
| Receipt number | R000072116 |
| Scientific Title | Evaluation of the effects of galvanic vestibular stimulation on anosognosia for hemiplegia |
| Date of disclosure of the study information | 2026/09/20 |
| Last modified on | 2026/09/19 15:49:10 |
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Basic information
Public title
A study of galvanic vestibular stimulation for impaired awareness of hemiplegia after stroke
Acronym
GVS-AHP Pilot Study
Scientific Title
Evaluation of the effects of galvanic vestibular stimulation on anosognosia for hemiplegia
Scientific Title:Acronym
GVS-AHP Pilot Study
Region
| Japan |
Condition
Condition
Anosognosia for hemiplegia following ischemic or hemorrhagic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to explore the effects of adding galvanic vestibular stimulation to usual rehabilitation on the severity of anosognosia for hemiplegia in patients with ischemic or hemorrhagic stroke. The secondary objectives are to evaluate changes in unilateral spatial neglect, motor function, activities of daily living, and cognitive function, as well as the persistence of the intervention effects and the feasibility of galvanic vestibular stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the severity score for anosognosia for hemiplegia assessed using the Visual-Analogue Test for Anosognosia for Motor Impairment (VATA-m), from the end of the A phase at 2 weeks after study initiation, immediately before GVS, to the end of the B phase at 4 weeks after study initiation, immediately after the 2-week GVS intervention
Key secondary outcomes
Scores or severity categories on Feinberg anosognosia questionnaire, the Bisiach anosognosia score, Catherine Bergego Scale total score, Fugl-Meyer Assessment upper- and lower-extremity scores, Functional Independence Measure score, and Mini-Mental State Examination score at baseline and at weeks 2, 4, and 6. Changes in the VATA-m severity score from baseline to week 2 and from week 4 to week 6.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A single-arm intervention with an A-B-A-prime phase structure in which galvanic vestibular stimulation is added to usual rehabilitation. The study period is 6 weeks. During the A phase (weeks 1-2), participants receive usual rehabilitation alone, including lower-extremity muscle strengthening, balance training, and gait training. During the B phase (weeks 3-4), galvanic vestibular stimulation is added to usual rehabilitation using the Intelect Advance Combo combination electrotherapy system (Chattanooga; medical device certification number: 220AIBZX00049000). Participants receive stimulation in a seated position with 3 x 3 cm electrodes placed over the bilateral mastoid processes. Stimulation is delivered for 15 minutes once daily on weekdays, 5 days per week for 2 weeks, for a total of 10 sessions. The stimulation intensity is individually adjusted within a tolerable, non-discomfort range based on the sensory threshold measured before the intervention and participant tolerability; the target intensity is approximately 1.5 mA. During the A-prime phase (weeks 5-6), participants receive usual rehabilitation alone again.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients admitted to the Convalescent Rehabilitation Ward of Kansai Electric Power Hospital
2.Patients diagnosed with ischemic or hemorrhagic stroke who present with hemiplegia
3.Patients judged to have anosognosia for hemiplegia based on an anosognosia assessment
4.Patients presenting with at least one of the following: unilateral spatial neglect or pusher syndrome
5.Patients for whom written informed consent to participate in the study is obtained from the participant or an appropriate legally authorized representative
Key exclusion criteria
1.Patients judged to have difficulty understanding the study procedures or cooperating with the study assessments because of severe dementia, aphasia, disorders of consciousness, or other conditions
2.Patients with implanted medical devices or metal materials that may interfere with study participation, such as a pacemaker, cochlear implant, or aneurysm clip, in the intracranial or cervical region
3.Patients with a history of epileptic seizures
4.Patients with skin disease or wounds at the mastoid processes, which are the stimulation sites
5.Patients whom the attending physician or principal investigator judges to be inappropriate for participation in the study for any other reason
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Takamatsu |
Organization
Kansai Electric Power Hospital
Division name
Department of Rehabilitation
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL
06-6458-5821
takamatsu.kenji@a5.kepco.co.jp
Public contact
Name of contact person
| 1st name | kenji |
| Middle name | |
| Last name | takamatsu |
Organization
Kansai Electric Power Hospital
Division name
Department of Rehabilitation
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
TEL
06-6458-5821
Homepage URL
takamatsu.kenji@a5.kepco.co.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Electric Power Hospital Research Ethics Committee
Address
2-1-7 Fukushima, Fukushima-ku, Osaka 553-0003, Japan
Tel
06-6458-5821
takamatsu.kenji@a5.kepco.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 19 | Day |
Last modified on
| 2026 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072116
