UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040590 |
|---|---|
| Receipt number | R000046327 |
| Scientific Title | Involvement of cervical muscle lesions and autonomic nervous system in treatment-resistant depression |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/05/30 14:56:55 |
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Basic information
Public title
Involvement of cervical muscle lesions and autonomic nervous system in treatment-resistant depression
Acronym
Treatment-resistant depression (TRD)
Scientific Title
Involvement of cervical muscle lesions and autonomic nervous system in treatment-resistant depression
Scientific Title:Acronym
Involvement of cervical muscle lesions and autonomic nervous system in treatment-resistant depression: Treatment-resistant depression (TRD)
Region
| Japan |
Condition
Condition
To clarify the involvement of cervical muscle lesions as well as the autonomic nervous system in patients with treatment-resistant depression
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the involvement of cervical muscle lesions as well as the autonomic nervous system in patients with treatment-resistant depression (TRD), this prospective study examined the effects of local modulation of cervical muscles by physical therapies in patients with TRD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Number of patients complaining cervical disorders in the self-rated records on the medical interview sheets before and after the physical treatments
2) Pupil light reflex parameters (the initial pupil diameter before the stimulus, the percentage of constriction rate and the velocity of the constriction) before and after the physical treatments
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 |
Interventions/Control_1
During hospitalization, all patients underwent local modulation of the cervical muscles through physical therapies: low-frequency electrical stimulation therapy and far-infrared irradiation for 15 minutes 2 or 3 times daily
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
| 10 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) TRD patients over the age of 10, who visited our institutions from May 2006 through April 2020.
2) Resistant to outpatient care
3) Patients who were hospitalized for 5 to 120 days were enrolled.
Key exclusion criteria
1) Diagnosed to have specific diseases in other organs after admission
2) Underwent surgeries of the cervical spine
3) Received other pharmacological or non-pharmacological treatments in addition to the physical therapies at their insistence
4) Quit the physical therapies due to adverse events that were judged to be therapy-related by the physicians
5) Dischaged themselves from the hospital based on their own judgement with unknown reasons.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo Neurological Center
Division name
Orthopaedics and Spine Department
Zip code
105-0001
Address
Toranomon 4-1-17, Minato-ku, Tokyo, Japa
TEL
+81-90-3002-5156
kawaguchi0126@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Fujii |
Organization
Tokyo Neurological Center
Division name
Office
Zip code
105-0001
Address
Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
TEL
+81-35776-1200
Homepage URL
fujii@tokyo-neurological-center.com
Sponsor or person
Institute
There is no outside sponsor associated with this study.
Institute
Department
Personal name
Funding Source
Organization
Tokyo Neurological Center
Matsui Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Neurological Center
Address
Toranomon 4-1-17, Minato-ku, Tokyo 105-0001, Japan
Tel
+81-35776-1200
fujii@tokyo-neurological-center.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
| 2020 | Year | 06 | Month | 30 | 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
2000
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
Terminated
Date of protocol fixation
| 2006 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046327
