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April. 26, 2021

Dec. 17, 2025

jRCTs032210054

An exploratory test for adults with autism spectrum disorder to develop new support methods based on fMRI neurofeedback (An fMR neurofeedback for adult ASD)

An fMRI neurofeedback for adults with autism spectrum disorder (An fMRI neurofeedback study for ASD)

Dec. 25, 2024

16

The study included male and female patients aged 20 years or older and under 50 years with autism spectrum disorder, who had no other major neuropsychiatric or physical comorbidities. A total of 16 participants provided written informed consent (mean age: 28.9 +- 8.2 years; 10 males and 6 females). All 16 participants were assigned to the intervention condition targeting functional connectivity within the default mode network.

A total of 16 participants provided informed consent for the intervention targeting functional connectivity within the default mode network, and 12 of them completed the entire study schedule. In the first year, six participants consented to participate; in the second year, five; and in the third year, another five. Because the primary research grant supporting this study ended in March 2024, and it was determined that obtaining additional funding necessary to achieve the target sample size of 40 participants using the same study design would be difficult, the study was discontinued on December 25, 2024. Analyses were conducted on the data from the 12 participants accumulated before discontinuation.

none

The results of the primary outcome measures were as follows. For the working memory task, performance was 1.64 +- 0.56 (mean +- SD) at the pre-assessment and 1.88 +- 0.64 at the post-assessment, showing no significant difference (t = -1.71, p = 0.11). Reaction time was not measured for this task. For the attention task, performance was 3.12 +- 1.01 at the pre-assessment and 3.20 +- 1.03 at the post-assessment, with no significant change (t = 0.30, p = 0.77). Reaction time was 0.76 +- 0.05 seconds at the pre-assessment and 0.75 +- 0.06 seconds at the post-assessment, also showing no significant difference (t = 0.82, p = 0.43). For the facial emotion recognition task, accuracy was 84.93 +- 10.30% at the pre-assessment and 84.99 +- 9.14% at the post-assessment, indicating no significant change (t = -0.04, p = 0.97). In contrast, reaction time was significantly reduced from 1.20 +- 0.44 seconds to 1.04 +- 0.32 seconds (t = 3.05, p = 0.01). For the inhibitory control task, reaction time was 122.51 +- 47.29 milliseconds at the pre-assessment and 104.50 +- 34.44 milliseconds at the post-assessment, showing a significant reduction (t = 2.71, p = 0.02). The results of secondary outcome measures were as follows. The neurofeedback (NF) performance scores were 55.68 +- 12.10 on the first day and 59.54 +- 13.57 on the second day, showing no significant difference (t = 1.59, p = 0.14). The functional connectivity within the default mode network (DMN) was 0.52 +- 0.19 at the pre-assessment and 0.51 +- 0.15 at the post-assessment, with no significant change (t = 0.19, p = 0.85). The Social Responsiveness Scale, Second Edition (SRS-2) scores were 96.33 +- 30.95 at the pre-assessment and 94.58 +- 45.92 at the post-assessment, showing no significant difference (t = 0.37, p = 0.72). The Conners Adult ADHD Rating Scale (CAARS) scores were 65.33 +- 16.37 at the pre-assessment and 62.83 +- 16.28 at the post-assessment. Although the difference was not statistically significant, a trend toward symptom reduction was observed (t = 1.93, p = 0.08). For the State-Trait Anxiety Inventory (STAI), the state anxiety scores were 35.08 +- 10.40 at the pre-assessment and 34.50 +- 10.18 at the post-assessment (t = 0.44, p = 0.68), and the trait anxiety scores were 51.42 +- 16.43 and 51.50 +- 16.17, respectively, showing no significant difference (t = -0.03, p = 0.98). The Beck Depression Inventory-II (BDI-II) scores were 14.92 +- 11.77 at the pre-assessment and 13.42 +- 12.02 at the post-assessment, showing no significant change (t = 0.99, p = 0.34). The Liebowitz Social Anxiety Scale-Japanese version (LSAS-J) scores were 53.58 +- 30.19 at the pre-assessment and 56.75 +- 36.69 at the post-assessment, with no significant difference (t = -0.81, p = 0.43).

We conducted fMRI neurofeedback training targeting changes in brain function in adults with autism spectrum disorder (ASD). The intervention focused on functional connectivity within the default mode network. 12 completed the full training schedule. Among the primary outcome measures, significant reductions in reaction times were observed in the post-intervention assessments for facial emotion recognition and the inhibition task. The study was terminated due to failure to reach the target sample size.

Nov. 30, 2025

Yes

No detailed schedule has been determined at this time.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210054

Ota Haruhisa

Medical Institute for Developmental Disabilities Research, Showa Medical University

6-11-11 Kita Karasuyama, Setagaya-ku, Tokyo, Japan

+81-3-5315-9357

haruhisap@gmail.com

Hashimoto Ryuichiro

Medical Institute for Developmental Disabilities Research, Showa Medical University

6-11-11 Kita Karasuyama, Setagaya-ku, Tokyo, Japan

+81-3-5315-9357

dbridges50@gmail.com

Complete

April. 26, 2021

Sept. 17, 2021
40

Interventional

single arm study

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

Adults with autism spectrum disorder

Patients who are inappropriate for MRI test

20age old over
50age old not

Both

autism spectrum disorder

Intervention group: Measure functional connectitiy in real-time and feedback the measurement to participants.
Control group: Give a dummy feedback to parcipants.

high-order brain function

D000067877

fMRI signal, cognitive test

Self-report questionnaire

AMED
Showa Medical University
SHOWA Medical Unviersity Clinical Research Review Board
1-5-8 Hatanodai Shinagawa-ku, Tokyo, JAPAN, Tokyo

+81-3-3784-8129

ura-ec@ofc.showa-u.ac.jp
Approval

Mar. 15, 2021

非該当

none

History of Changes

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11 Dec. 17, 2025 (this page) Changes
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