N/A
Completed N=65
A Novel fNIRS Neurofeedback Intervention for Enhancement of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT04002167 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change in Target Frontal-parietal Activity — 2.31; -4.74 beta coefficient
Summary
The proposed study is to test and validate a novel intervention that integrates computerized cognitive training with real-time neuromonitoring and neurofeedback to enhance working memory by probing the individualized neural systems underlying working memory. We will test the proposed intervention on children with ADHD with working memory deficits. The R61 proof-of-concept phase will assess the target engagement, effective dose and feasibility.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Target Frontal-parietal Activity |
2.31; -4.74 | — |
| PRIMARY Change in Working Memory Performance |
2.12; -0.53 | — |
| SECONDARY Change in Behavior Rating Inventory of Executive Function (BRIEF), Working Memory T-score |
-8.4; -0.85 | — |
| SECONDARY Change in Wide Range Assessment of Memory and Learning 2 (WRAML-2), General Memory Index Score |
6.6; 9.38 | — |
| SECONDARY Change in Conners 3rd Edition ADHD Index Score |
-6.21; -1 | — |
| SECONDARY Change in Conners 3rd Edition Inattention T-score |
-4.8; 0.41 | — |
| SECONDARY Change in Developmental NEuroPSYchological Assessment II (NEPSY-II) Composite Score |
0.72; 1.05 | — |
Eligibility Criteria
Inclusion criteria include:
- Age from 7 to 11 years
- Diagnosis and/or current symptoms of ADHD
- Full-scale Intelligence quotient (IQ) ≥80
- Behavior Rating Inventory of Executive Functions (BRIEF), Working Memory Scale t-score > 65
- Allowed comorbidities include oppositional defiant disorder, learning disabilities excluding dyslexia, and mild anxiety and/or depression.
Exclusion criteria
- Presence of severe neurological or psychiatric disease other than those allowed under inclusion
- Sensory deficits that would preclude participation in assessments or imaging
- History of significant head trauma with loss of consciousness
- Contraindications to MRI (e.g. metal implants or claustrophobia)
- Enrollment in other intervention studies
Data sourced from ClinicalTrials.gov (NCT04002167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.