UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062543 |
|---|---|
| Receipt number | R000069215 |
| Scientific Title | An exploratory study of known and unknown positive signs for the accurate diagnosis of functional neurological disorder (FND) |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/10 16:22:14 |
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Basic information
Public title
A study examining neurological findings useful for diagnosing functional neurological disorder
Acronym
FND-Signs Study
Scientific Title
An exploratory study of known and unknown positive signs for the accurate diagnosis of functional neurological disorder (FND)
Scientific Title:Acronym
EXPLORE-FND Study
Region
| Japan |
Condition
Condition
Functional neurological disorder
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to prospectively evaluate the diagnostic accuracy (sensitivity and specificity) of multiple positive signs for differentiating functional weakness from organic weakness, and to assess the inter-rater agreement (reliability) of these positive signs among multiple physician evaluators.
Basic objectives2
Others
Basic objectives -Others
An additional objective of this study is to exploratorily examine the characteristics and combinations of multiple positive signs and to descriptively summarize their clinical usefulness for the diagnosis of functional weakness.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic accuracy (sensitivity and specificity) of pre-specified positive signs for differentiating functional weakness from organic weakness.All assessments will be performed at the time of enrollment during the same clinical visit.
Key secondary outcomes
1 Inter rater agreement of positive signs.
Inter rater agreement among physician evaluators for each positive sign will be assessed using Cohen kappa statistics. All assessments will be performed at the time of enrollment during the same clinical visit.
2 Between group differences in muscle strength measurements.
Differences in grip strength measured using a dynamometer in kilograms and manual muscle testing scores graded from zero to five between patients with functional weakness and those with organic weakness will be evaluated. All assessments will be performed at the time of enrollment during the same clinical visit.
3 Diagnostic accuracy of exploratory positive signs.
Diagnostic accuracy including sensitivity and specificity of exploratory positive signs identified during neurological examination will be evaluated.All assessments will be performed at the time of enrollment during the same clinical visit.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged eighteen years or older presenting with muscle weakness or sensory disturbance as neurological symptoms and who are able to undergo neurological examination and manual muscle testing.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded.
1 Patients with severe cognitive impairment that makes it difficult to understand the study or to provide informed consent.
2 Patients with aphasia that interferes with understanding the study or undergoing neurological examination.
3 Patients with severe psychiatric disorders that make participation in the study or accurate assessment difficult.
4 Patients with other comorbid conditions that make accurate evaluation using neurological examination including manual muscle testing difficult.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohira |
Organization
National Center of Neurology and Psychiatry (NCNP) National Center Hospital
Division name
Department of Clinical Laboratory
Zip code
187-8551
Address
4-1-1, Ogawa-higashi cho, Kodaira Tokyo
TEL
0423412712
maohira@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohira |
Organization
National Center of Neurology and Psychiatry (NCNP) National Center Hospital
Division name
Department of Clinical Laboratory
Zip code
187-8551
Address
4-1-1, Ogawa-higashi cho, Kodaira Tokyo
TEL
0423412712
Homepage URL
maohira@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry National Center
Institute
Department
Personal name
Masayuki Ohira
Funding Source
Organization
National Center of Neurology and Psychiatry National Center
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
National Center of Neurology and Psychiatry National Center Clinical Research Ethics Committee
Address
4-1-1, Ogawa-higashi cho, Kodaira Tokyo
Tel
042-341-2712
ml_rinrijimu@ncnp.go.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 | 08 | Month | 31 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study designed to evaluate diagnostic accuracy.Participants undergo neurological examination manual muscle testing and grip strength measurement once at enrollment during a single clinical visit as part of routine clinical care.Two groups consisting of functional weakness and organic weakness are observed in parallel and diagnostic accuracy and inter rater agreement of positive signs are analyzed.Assessment of positive signs is performed independently by two physicians who have no access to prior diagnostic information.No therapeutic intervention medication or additional procedure is performed in this study.
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069215
