UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061748 |
|---|---|
| Receipt number | R000070610 |
| Scientific Title | Evaluation of Intracortical Inhibition and Facilitation in Eating Disorders Using Paired-Pulse Transcranial Magnetic Stimulation |
| Date of disclosure of the study information | 2026/06/02 |
| Last modified on | 2026/05/31 22:34:37 |
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Basic information
Public title
A Study Using Transcranial Magnetic Stimulation Testing to Examine the Brain Excitation and Inhibition in Eating Disorders
Acronym
ED TMS Assessment Study
Scientific Title
Evaluation of Intracortical Inhibition and Facilitation in Eating Disorders Using Paired-Pulse Transcranial Magnetic Stimulation
Scientific Title:Acronym
ED Paired-Pulse TMS Study
Region
| Japan |
Condition
Condition
Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate alterations in intracortical inhibition and facilitation, which are considered to reflect GABAergic and glutamatergic neural functions, in patients with eating disorders using paired-pulse transcranial magnetic stimulation, and to examine their associations with response inhibition and clinical symptoms.
Basic objectives2
Others
Basic objectives -Others
Neurophysiological assessment using transcranial magnetic stimulation testing
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intracortical inhibition and facilitation indices derived from motor evoked potentials recorded from the right first dorsal interosseous muscle using transcranial magnetic stimulation, including SICI, LICI, ICF, and cortical silent period
Key secondary outcomes
Behavioural measures assessed using response inhibition tasks, and clinical assessment measures including the severity of eating disorder symptoms
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible participants are Japanese individuals who meet the DSM-5-TR diagnostic criteria for an eating disorder, including anorexia nervosa, bulimia nervosa, or binge-eating disorder, and who have visited the Department of Psychiatry at Chiba University Hospital. Due to practical constraints in study implementation, recruitment will primarily focus on patients with anorexia nervosa; however, patients with bulimia nervosa or binge-eating disorder may also be enrolled if they meet the eligibility criteria. Participants must be 16 to 65 years of age at the time of informed consent. Participants may also be recruited through the Internet or posted advertisements; however, eligibility will be assessed at the time of informed consent at the Department of Psychiatry of Chiba University Hospital.
Key exclusion criteria
1. Individuals with psychiatric disorders that preceded the onset of the eating disorder and may substantially affect the assessment of eating disorder pathology, such as schizophrenia spectrum disorders, bipolar disorder, or alcohol or substance use disorders.
2. Individuals with severe physical illnesses.
3. Individuals with a past or current history of central nervous system disorders, other than the target disease, including epilepsy or head injury associated with loss of consciousness.
4. Individuals with metal objects or devices in the head region, including cochlear implants, ferromagnetic clips, deep brain stimulation devices, or vagus nerve stimulation devices, or those with cardiac pacemakers.
5. Individuals who have not been informed of their diagnosis at the time of obtaining consent.
6. Women who are pregnant, may be pregnant, or are breastfeeding.
7. Individuals whose worsening clinical condition makes it difficult for them to fully understand the study and to decide whether to participate.
8. Individuals judged by the attending physician or study physician to be unsuitable for participation in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Kanahara |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of Clinical Neuroscience
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Japan, Research Building of Medical Science 5F
TEL
0432227171
cfmh-jim@office.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sudo |
Organization
Chiba University Center for Forensic Mental Health
Division name
Division of Clinical Neuroscience
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Japan, Research Building of Medical Science 5F
TEL
0432227171
Homepage URL
cfmh-jim@office.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Chiba University
Address
1-8-1Inohaba, Chuo-ku, Chiba, Chiba
Tel
0432511111
inohana-rinri@chiba-u.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 | 06 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cross-sectional observational study. Patients who meet the DSM-5-TR diagnostic criteria for an eating disorder and healthy control participants will undergo transcranial magnetic stimulation testing, response inhibition tasks, and clinical assessments. The study will examine the associations of intracortical inhibition and facilitation indices and cortical silent period assessed using transcranial magnetic stimulation with eating disorder symptoms, response inhibition, and other clinical measures. Participants will be enrolled from outpatients at the study institution, applicants recruited through the Internet or posted advertisements, and referred individuals who meet the eligibility criteria.
Management information
Registered date
| 2026 | Year | 05 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070610
