fNIRS Neurofeedback in Highly Impulsive Participants With ROI Regions DLPFC and IFG

NCT05863169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-05-17

No results posted yet for this study

Summary

The aim of the following study is to investigate which is the best region of interest (ROI) for a functional near-infrared spectroscopy (fNIRS)-based neurofeedback (NF) training for highly-impulsive individuals (and consequently also patients with attention-deficit/hyperactivity disorder, ADHD): the dorsolateral prefrontal cortex (DLPFC) or the inferior frontal gyrus (IFG). Generally, NF trainings aim to improve the neurophysiological as well as cognitive-behavioral deficits observed in many neuropsychiatric disorders and were shown to constitute an effective complementary treatment option for patients with ADHD. Some previous studies used the DLPFC as a ROI for NF training, while others focused on the IFG as the main target region. However, so far, no study has directly compared the effectiveness of NF trainings targeting the DLPFC vs. IFG using the same protocol or the specificity of regulation efforts between these two areas using fNIRS. Therefore, the aim of the current study is to compare the effectiveness of fNIRS-NF using the DLPFC as a ROI with fNIRS-NF using the IFG as a ROI in a randomized controlled study design with highly-impulsive, healthy participants.

Furthermore, the investigators aim to test the effect of fNIRS-NF training in the context of stress. Previous studies reported that there is a strong connection between ADHD and stress. However, the effect of fNIRS-NF training for the adaptation to stressful situations is uncertain.

To this end, the investigators will assess the brain activity of participants before and after an fNIRS-NF training period during performance of a Go/NoGo task, an n-back task and The Trier Social Stress Test (TSST). It is hypothesized that both trainings will be successful in reducing impulsive behavior; however, in the pre/post testing, specific effects of fNIRS-based NF of the DLPFC are expected on working memory function and of fNIRS-based NF of the IFG on inhibitory control (Go/NoGo task). Correlations between both functions and impulsive symptoms will give an indication which training ROI may be more promising for the treatment of (specific subgroups of) ADHD. Correlations between regulation of different training ROIs will indicate the specificity of feedback regulation of circumscribed cortical areas.

Conditions

  • Impulsivity

Interventions

DEVICE

fNIRS-Neurofeedback

Neurofeedback of cortical oxygenation in 4 channels (2 left hemisphere, 2 right hemisphere); 8 training sessions, each session includes 2 feedback blocks (2\*12 activation/deactivation trials) and one transfer block (8 activation/deactivation trials)

Sponsors & Collaborators

  • Japan society for the promotion of science

    collaborator UNKNOWN
  • Nakatani foundation and Japan foundation for pediatric research

    collaborator UNKNOWN
  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Ann-Christine Ehlis, PhD · University Hospital Tübingen, Dpt. of Psychiatry and Psychotherapy, Group leader: Psychophysiology & Optical Imaging

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-07-12
Completion
2021-07-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05863169 on ClinicalTrials.gov