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

NCT05863169 | Completed

• 1 other identifier: 100/2018BO2
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• Change of n-back reaction times after neurofeedback training compared to baseline

  Reaction times (mean and standard deviation) obtained during a block-design n-back (working memory) task (0-back, 1-back, and 3-back condition)

  Change from baseline to immediately after the 8th neurofeedback training session

• Change of n-back error rates after neurofeedback training compared to baseline

  Error rates (hits, misses, false alarms) obtained during a block-design n-back (working memory) task (0-back, 1-back, and 3-back condition)

  Change from baseline to immediately after the 8th neurofeedback training session

• Change of Go/NoGo reaction times after neurofeedback training compared to baseline

  Reaction times (mean and standard deviation) obtained during a Go/NoGo task (Go and NoGo blocks)

  Change from baseline to immediately after the 8th neurofeedback training session

• Change of Go/NoGo error rates after neurofeedback training compared to baseline

  Error rates (hits, misses, false alarms) obtained during a Go/NoGo task (Go and NoGo blocks)

  Change from baseline to immediately after the 8th neurofeedback training session

• Change of N-back brain activation data (fNIRS) after neurofeedback training compared to baseline

  Oxygenation changes (fNIRS data) during the 3-back, 1-back, and 0-back condition of the n-back task in pre-defined regions of interest (DLPFC \[Brodman area/BA9 and 46\], IFG, temporal cortex)

  Change from baseline to immediately after the 8th neurofeedback training session

• Change of Go/NoGo brain activation data (fNIRS) after neurofeedback training compared to baseline

  Oxygenation changes (fNIRS data) during the Go and NoGo condition of the go-nogo task in pre-defined regions of interest (DLPFC \[BA9 and 46\], IFG, temporal cortex)

  Change from baseline to immediately after the 8th neurofeedback training session

• Neurofeedback learning success based on the online feedback signal (number of correct trials)

  Increase in the number of successful neurofeedback training trials from session 1 to session 8 (for feedback and transfer trials, up- and down-regulation)

  Change from neurofeedback session 1 to session 8

• Neurofeedback learning success based on the online feedback signal (percentage of correct time-points)

  Increase in the percentage of time-points (in the second half of all neurofeedback regulation trials) where the fNIRS feedback signal was regulated in the correct direction from session 1 to session 8 (for feedback and transfer trials, up- and down-regulation)

  Change from neurofeedback session 1 to session 8

• Neurofeedback learning success based on an offline analysis of successful up- vs. down-regulation

  Increase in the differentiation between up- and down-regulation of the fNIRS signal from session 1 to session 8 (for feedback, transfer and all trials; offline analysis)

  Change from neurofeedback session 1 to session 8

Secondary Outcomes (4)

• Correlation of internal-external control beliefs with neurofeedback learning outcome

  Baseline/pre-intervention

• Correlation of trait impulsivity with neurofeedback learning outcome

  Baseline/pre-intervention

• Correlation of general self-efficacy with neurofeedback learning outcome

  Baseline/pre-intervention

• Correlation of trait anxiety with neurofeedback learning outcome

  Baseline/pre-intervention

Study Arms (3)

dlPFC fNIRS-Feedback

EXPERIMENTAL

Feedback of oxygenation in 4 DLPFC channels

Device: fNIRS-Neurofeedback

IFG fNIRS-Feedback

EXPERIMENTAL

Feedback of oxygenation in 4 IFG channels

Device: fNIRS-Neurofeedback

Control fNIRS-Feedback

ACTIVE COMPARATOR

Feedback of oxygenation in 4 control channels over temporal areas (unrelated to cognitive control or ADHD)

Device: fNIRS-Neurofeedback

Interventions

fNIRS-Neurofeedback DEVICE

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)

Control fNIRS-Feedback; IFG fNIRS-Feedback; dlPFC fNIRS-Feedback

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed written consent
• ASRS score in subscale (Items 10 bis 18) "hyperactivity/impulsivity" \>=17
• No additional serious physical, neurological or mental disorder.

You may not qualify if:

• ASRS score "hyperactivity/impulsivity"\<17
• Self-reported diagnosis of one or more of the following
• Serious physical or chronic illness such as lung disease, heart disease, diabetes (E10-E14 according to ICD-10), hypertension (I10.x according to ICD-10), and rheumatic diseases
• Neurological disorders including stroke, multiple sclerosis and epilepsy
• History of moderate or severe craniocerebral injury (GCS 3-12) / second or third degree craniocerebral injury with period of unconsciousness exceeding 30 minutes
• Indicated psychiatric disorders including bipolar disorder, psychosis, obsessive-compulsive disorder, chronic tics, Tourette syndrome, and suicidal behavior; in addition to self-report, these will be screened for by using the SCID (Structured Clinical Interview for DSM-IV) screening questions
• Prior participation in a NF training.
• Other psychotherapeutic treatment or any kind of attention training, also in the course of an ergotherapeutic treatment, while participating in the study

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Japan society for the promotion of science: collaborator
• Nakatani foundation and Japan foundation for pediatric research: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ann-Christine Ehlis, PhD

  University Hospital Tübingen, Dpt. of Psychiatry and Psychotherapy, Group leader: Psychophysiology & Optical Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: May 17, 2023
• Study Start: January 30, 2019
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: May 17, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)