UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062585 |
|---|---|
| Receipt number | R000071045 |
| Scientific Title | Feasibility and Clinical Utility of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program for Patients with Depression |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/08/15 14:21:12 |
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Basic information
Public title
Feasibility and Clinical Utility of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program for Patients with Depression
Acronym
Feasibility and Clinical Utility of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program for Patients with Depression
Scientific Title
Feasibility and Clinical Utility of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program for Patients with Depression
Scientific Title:Acronym
An Intervention Study of a Combined Repetitive Transcranial Magnetic Stimulation (rTMS) and Occupational Therapy Program
Region
| Japan |
Condition
Condition
mood disorder (depressive disorder)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to provide occupational therapy in combination with transcranial magnetic stimulation (TMS) treatment for patients with depression and to examine its feasibility and clinical utility.
Specifically, this study will assess the consent rate, intervention initiation rate, retention rate, assessment completion rate, reasons for discontinuation, adverse events, and patient acceptability. In addition, changes in depressive symptoms, cognitive function, physical activity, daily functioning, and social functioning will be evaluated exploratorily.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depression and Anxiety Scales
1. Hamilton Depression Rating Scale, 17-item version (HAM-D17)
2. Hamilton Depression Rating Scale, 21-item version (HAM-D21)
3. Patient Health Questionnaire-9 (PHQ-9)
4. Beck Depression Inventory-II (BDI-II)
5. Zung Self-Rating Depression Scale (SDS)
6. State-Trait Anxiety Inventory (STAI)
Social and Daily Functioning
7. Social Adaptation Self-evaluation Scale, Japanese version (SASS-J)
8. World Health Organization Disability Assessment Schedule 2.0, 12-item version (WHODAS 2.0)
Medication Adherence
9. Drug Attitude Inventory-10 (DAI-10)
Cognitive Function
10. Brief Assessment of Cognition in Schizophrenia (BACS)
Physical Fitness Assessment
11. Six-Minute Walk Test (6MWT)
Occupational Performance and Executive Function
12. Canadian Occupational Performance Measure (COPM)
13. Modified Tinkertoy Test (m-TTT)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Combination of Repetitive Transcranial Magnetic Stimulation and Occupational Therapy: Feedback on Activity Levels and Mood
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with depression by a physician and deemed eligible for repetitive transcranial magnetic stimulation (rTMS) treatment.
Key exclusion criteria
1Individuals from whom written informed consent for participation in the study cannot be obtained.
2Individuals with a diagnosis of intellectual disability who are judged by the principal investigator to have difficulty understanding the study procedures or completing the study assessments.
3Individuals with a history of head injury or neurological disease that may affect study safety or outcome assessments.
4Individuals experiencing acute intoxication with, or withdrawal from, alcohol or other substances.
5Individuals who are considered unsuitable for participation in the study by the principal investigator or attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
Department of Rehabilitation Science, School of Health Sciences
Zip code
475-0012
Address
26-2 Higashi-Ikemi-cho, Handa City, Aichi Prefecture
TEL
0569200131
n-yasu@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Nakamura |
Organization
Nihon Fukushi University
Division name
School of Health Sciences
Zip code
475-0012
Address
26-2,Higashighaemi-cho
TEL
0569200131
Homepage URL
n-yasu@n-fukushi.ac.jp
Sponsor or person
Institute
Kasadera Seichiryou Hospital
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
Kasadera Seichiryou Hospital Ethics Committee
Address
3 Yunoki, Kasadera-cho, Minami-ku, Nagoya, Aichi, Japan
Tel
052-821-9221
kasadera-ot@seichiryo.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 08 | Month | 15 | Day |
Last modified on
| 2026 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071045
