UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060274 |
|---|---|
| Receipt number | R000068947 |
| Scientific Title | Informational Perturbation Resolves Precision Collapse and Restores Adaptive Neural Dynamics |
| Date of disclosure of the study information | 2026/01/06 |
| Last modified on | 2026/01/06 19:27:29 |
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Basic information
Public title
Informational Perturbation Resolves Precision Collapse and Restores Adaptive Neural Dynamics
Acronym
Informational Perturbation Resolves Precision Collapse and Restores Adaptive Neural Dynamics
Scientific Title
Informational Perturbation Resolves Precision Collapse and Restores Adaptive Neural Dynamics
Scientific Title:Acronym
Informational Perturbation Resolves Precision Collapse and Restores Adaptive Neural Dynamics
Region
| Japan |
Condition
Condition
Neural functional frozen attractor
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the computational mechanisms of the brain's proprioceptive prediction error processing. Specifically, we aim to verify whether a specific light-touch
intervention (Specific Informational Perturbation: SIP) can reset frozen neural dynamics and restore adaptive physiological states.
This research comprises three sub-studies:
Study 1 (RCT): Investigates the existence of the effect compared to a sham (placebo).
Study 2 (Specificity): Investigates whether the effect depends on the type of stimulus.
Study 3 (Ecological): Validates the effect in a home environment.
Basic objectives2
Others
Basic objectives -Others
Phase transition of frozen attractor by using specific informational perturbation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We utilize Systemic Active Inference Metrics (SAIM), a novel framework of physiological indicators derived from EEG and heart rate variability (HRV) data.
F (Free Energy Proxy): A metric indicating systemic uncertainty.
NCI (Neural Complexity Index): A measure reflecting the complexity of neural activity.
HEMO (Hemodynamic Coupling): An index representing neurovascular coupling.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Specific informational perturbation
Interventions/Control_2
Sham
Interventions/Control_3
Predictable informational perturbation
Interventions/Control_4
Mismatch informational perturbation
Interventions/Control_5
Specific informational perturbation under each subject's home
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Health Status: Participants were healthy individuals with no history of psychiatric or neurological disorders and were not currently using psychotropic or neuroactive medications.
Inclusion Criteria: Inclusion was restricted to individuals demonstrating latent proprioceptive deficits at baseline, defined as a Free Energy Proxy ($F$) > 0.8.
Key exclusion criteria
Psychiatric or neurological disorders and were currently prescribed psychotropic or neuroactive medications
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Shiga |
Organization
TIC-DO Institute
Division name
Research Director
Zip code
107-0052
Address
Tokyo, Minato, Akasaka9-6-29, Pacific Nogizaka407
TEL
08067573213
info@tic-straight.com
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Shiga |
Organization
TIC-DO
Division name
Research
Zip code
107-0052
Address
Tokyo, Minato, Akasaka9-6-29, Pacific Nogizaka407
TEL
08067573213
Homepage URL
info@tic-straight.com
Sponsor or person
Institute
TIC-DO institute
Institute
Department
Personal name
Takafumi Shiga
Funding Source
Organization
TIC-DO institute
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TIC-DO IRB
Address
Tokyo, Minato, Akasaka9-6-29, Pacific Nogizaka407
Tel
08067573213
info@tic-straight.com
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
カイロプラクティックオフィス“ストレート”
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 06 | 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
Study has not started yet; N/A
Results date posted
| 2026 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Study has not started yet; N/A
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068947
