UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024831 |
|---|---|
| Receipt number | R000028571 |
| Scientific Title | A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2024/07/18 18:46:43 |
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Basic information
Public title
A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Acronym
A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Scientific Title
A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Scientific Title:Acronym
A research for clinical application of real-time functional magnetic resonance imaging neurofeedback for treatment of schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to change functional brain connectivity selected with data-driven analysis, using real-time functional magnetic resonance imaging neurofeedback (NFB), and evaluate the efficacy and safety of NFB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive and Negative Symptoms Scale (PANSS)
Key secondary outcomes
The Global Assessment of Functioning (GAF)
The Brief Assessment of Cognition in Schizophrenia (BACS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
One NFB session in fMRI scanner will be conducted once a day, and 5 days a week. After 5-10 sessions (in one or 2 weeks), symptoms and conditions of participants will be evaluated.
Interventions/Control_2
N-back cognitive training for approximately one hour per day, five days per week.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants need to be outpatients of department of psychiatry, Kyoto University.
2. Participants need to be diagnosed as schizophrenia and other psychotic disorders, or schizophrenia spectrum in DSM-IV-TR or DSM-V.
3. Participants need to have normal or corrected visual acuity.
4. Age at the time of enrolment need to be over 20 years old and under 50 years old.
5. Participants need to give informed consent by themselves on paper.
Key exclusion criteria
1. User of cardiac pacemaker
2. User of brain vascular clip
3. User of electric stimulator for neurons
4. User of implanted pump in body
5. One having remaining metallic piece in one's body
6. One having tattoo
7. One having treatment with electroconvulsive therapy
8. One having comorbid disorder below,
Seizure or other neurological disease
Substance related disorders
Severe heart disease
9. One having past history below,
Seizure or other neurological disease
Substance related disorders
Brain injury with loss of consciousness
10. Female having possibility of pregnancy. Female having breast-feeding. Male of Female not using birth control during research
11. One having been judged as inappropriate for research by researcher and doctors.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Yoshihara |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL
0757513386
yujiroyo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Yoshihara |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 Shogoin-Kawara-cho Sakyo-ku Kyoto
TEL
0757514947
Homepage URL
yujiroyo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Advanced Telecommunications Research Institute International (ATR)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53, Kawahara-tyo, Syogo-in, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-753-4680
ethcomkuhp@kyoto-u.ac.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
| 2017 | Year | 02 | Month | 01 | 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
20
Results
A two-arm non-randomized exploratory study was conducted with 20 patients with schizophrenia, 11 in the fMRI neurofeedback group and 9 in the cognitive control group (8 eligible for analysis). The fMRI neurofeedback group did not experience any illness or other adverse events. There was an interaction effect (F[1,17] = 4.983, uncorrected p = 0.039) on the digit span backward task and a post-intervention improvement on the time factor in the neurofeedback group.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven participants in the neurofeedback group consisted of 7 males and 4 females, with an average age of 38.82 (standard error 7.47) years. Eight participants in the cognitive training group included 5 males and 3 females, with an average age of 36.53 (standard error 10.88) years. The cognitive training group initially included nine participants, but one was excluded from the analysis because they exceeded the criteria in the pre-intervention assessments.
There were no significant differences between the two groups in the following items: age, duration of illness, chlorpromazine equivalent value (antipsychotic medications), estimated premorbid IQ, years of education, socioeconomic status (participants), and socioeconomic status (parents). Student's t-tests were performed for all items except gender, for which Fisher's exact test was used. A two-tailed test with a significance level of 0.05 was applied.
Participant flow
Eleven neurofeedback group participants were measured between August 2017 and March 2020, and nine cognitive training group participants were measured between February 2021 and February 2022. One cognitive training group participant was excluded from subsequent analyses because they exceeded the criteria in the pre-intervention assessment.
Adverse events
No occurrence of illness or other adverse events was observed in either group.
Outcome measures
A repeated measures analysis of variance was performed on the time and group factors using a two-tailed test with a significance level of 0.05. No multiple comparison correction was applied between rating scales. For the primary outcomes, a significant difference in the time factor was found for the PANSS total score (p = 0.043, F[1,17] = 4.765, partial eta-squared = 0.219), positive score( p = 0.040, F[1,17] = 4.956, partial eta-squared = 0.226), and cognitive factor(p = 0.022, F[1,17] = 6.327, partial eta-squared = 0.271) (Lindenmayer et al., 1995), with symptoms improvement after the intervention, and interaction effects was not observed. No main effects or interaction effects were found for the negative or general scores. No main effects or interaction effects were found for the secondary outcomes SWM between errors, SWM strategy, RTI five-choice mean reaction time, and RTI five-choice mean movement time. BACS was not performed in all subjects.
There was an interaction effect (F[1,17] = 4.983, uncorrected p = 0.039) on the digit span backward task and a postintervention
improvement (p = 0.023) on the time factor in the neurofeedback group.
Plan to share IPD
Yes
IPD sharing Plan description
If subjects consent, the data will be made available as an anonymized data resource for collaborative research projects with other research institutions.
We will provide anonymized information to a database containing many samples of human and primate (macaque and marmoset) brain images taken with MRI and accompanying clinical information as part of the "Strategic International Brain Science Research Promotion Program" of the Japan Agency for Medical Research and Development (AMED)
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028571
